Energy delivery systems and uses thereof

ABSTRACT

Provided herein are devices, systems, and methods for delivering energy to tissue for a wide variety of applications, including medical procedures (e.g., tissue ablation, resection, cautery, vascular thrombosis, treatment of cardiac arrhythmias and dysrhythmias, electrosurgery, tissue harvest, etc.). In certain embodiments, devices, systems, and methods are provided for delivering energy to difficult to access tissue regions (e.g. central or peripheral lung tissues), and/or reducing the amount of undesired heat given off during energy delivery.

FIELD OF THE INVENTION

Provided herein are devices, systems, and methods for delivering energyto tissue for a wide variety of applications, including medicalprocedures (e.g., tissue ablation, resection, cautery, vascularthrombosis, treatment of cardiac arrhythmias and dysrhythmias,electrosurgery, tissue harvest, etc.). In certain embodiments, devices,systems, and methods are provided for delivering energy to difficult toaccess tissue regions (e.g. central or peripheral lung tissues), and/orreducing the amount of undesired heat given off during energy delivery.

BACKGROUND

Ablation is an important therapeutic strategy for treating certaintissues such as benign and malignant tumors, cardiac arrhythmias,cardiac dysrhythmias and tachycardia. Most approved ablation systemsutilize radio frequency (RF) energy as the ablating energy source.Accordingly, a variety of RF based catheters and power supplies arecurrently available to physicians. However, RF energy has severallimitations, including the rapid dissipation of energy in surfacetissues resulting in shallow “burns” and failure to access deeper tumoror arrhythmic tissues. Another limitation of RF ablation systems is thetendency of eschar and clot formation to form on the energy emittingelectrodes which limits the further deposition of electrical energy.

Microwave energy is an effective energy source for heating biologicaltissues and is used in such applications as, for example, cancertreatment and preheating of blood prior to infusions. Accordingly, inview of the drawbacks of the traditional ablation techniques, there hasrecently been a great deal of interest in using microwave energy as anablation energy source. The advantage of microwave energy over RF is thedeeper penetration into tissue, insensitivity to charring, lack ofnecessity for grounding, more reliable energy deposition, faster tissueheating, and the capability to produce much larger thermal lesions thanRF, which greatly simplifies the actual ablation procedures.Accordingly, there are a number of devices under development thatutilize electromagnetic energy in the microwave frequency range as theablation energy source (see, e.g., U.S. Pat. Nos. 4,641,649, 5,246,438,5,405,346, 5,314,466, 5,800,494, 5,957,969, 6,471,696, 6,878,147, and6,962,586; each of which is herein incorporated by reference in theirentireties).

Unfortunately, current devices are limited, by size and flexibility, asto the body regions to which they are capable of delivering energy. Forexample, in the lungs, the air paths of the bronchial tree getprogressively narrower as they branch with increasing depth into theperiphery of the lungs. Accurate placement of energy delivery devices tosuch difficult to reach regions is not feasible with current devices.Further, existing microwave systems are incapable of delivery sufficientmicrowave energy to distant ablation target regions without overheatingand burning tissue along the pathway. Improved systems and devices fordelivering energy to difficult to reach tissue regions are needed.

SUMMARY OF THE INVENTION

Provided herein are devices, systems, and methods for delivering energyto tissue for a wide variety of applications, including medicalprocedures (e.g., tissue ablation, resection, cautery, vascularthrombosis, treatment of cardiac arrhythmias and dysrhythmias,electrosurgery, tissue harvest, etc.). In certain embodiments, devices,systems, and methods are provided for delivering energy to difficult toaccess tissue regions (e.g. central and peripheral lung tissues), and/orreducing the amount of undesired heat given off during energy delivery.In some embodiments, systems, devices, and methods are provided forreducing heat release along energy transmission lines.

In some embodiments, provided herein are systems, devices, and methodsthat employ components for the delivery of energy to a tissue region(e.g., tumor, lumen, organ, etc.). In some embodiments, the systemcomprises an energy delivery device and one or more of: a processor, apower supply, a components for directing, controlling and deliveringpower (e.g., a power splitter), an imaging system, a tuning system, atemperature adjustment system, and a device placement system.

There are a number of significant challenges to delivering ablativeamounts of energy to distant or hard-to-reach locations within a body(e.g., central and peripheral lung tissues). For example, forendobronchial or transbronchial therapies, such techniques may requirelong, flexible delivery pathways and small diameter devices. Thesefactors complicate the delivery of sufficiently high amounts of energyto the target tissue. Increasing energy delivery along such a pathcreates significant heating and poses challenges to the materials used.Heating can burn tissue along the pathway causing undesired orunacceptable damage. Provided herein are devices, system, and methodsthat overcome these challenges and balance the factors needed to achievesuccessful tissue ablation with long, flexible, small diameter devicesable to reach remote areas of the body (e.g., endobronchially andtransbronchially).

In some embodiments, the devices, systems, and methods employ a co-axialor triaxial microwave energy delivery device having coolant flowedthrough a first channel of the device from its proximal end to itsdistal end and wherein the coolant is reversed at the distal end andflows back through the device distal to proximal through a differentchannel. In some embodiments, the first channel is provided in a hollowcenter of an inner conductor and the return channel is provided betweenthe inner and outer conductors.

For example, in some embodiments, provided herein is an energy deliverydevice for delivering microwave energy to a distant region of a body,comprising one or more or each of: a) a proximal end connectable orconnected, directly or indirectly, to a microwave energy generatorand/or a coolant source; b) a distal end configured to generate ablativeenergy in a defined region surrounding the distal end so as to ablate adesired tissue region; c) an inner conductor (e.g., a hollow innerconductor; d) a spacer surrounding a portion of the inner conductor(e.g., a monofilament tube spiraled around the inner conductor); e) anon-conductive core (e.g., dielectric core) surrounding the spacer,whereby an air gap is formed between the core and the inner conductor inregions not occupied by the spacer; f) an outer conductor surroundingthe core; and a coolant flow exchanger at the distal end configured toreceive coolant from one source (e.g., a hollow inner conductor) andreturn coolant to the air gap.

In some embodiments, the energy delivery device is sufficiently long toextend from outside of the body to a target region inside of the body.Thus, in some embodiments, the energy delivery device is at least 20centimeter longs (e.g., at least 30, 40, 50, 60, 70, 80, 90, 100, 110,120, 130, 140, 150, 160, 170, 180, 190, 200, etc. cm longs or rangestherein between).

In some embodiments, the energy delivery device further comprises anon-conductive jacket surrounding the outer conductor. In someembodiments, the energy delivery device further comprises a conductivesheath surrounding the non-conductive jacket, the conductive sheathforming a triaxial antenna with the outer conductor and the innerconductor.

In some embodiments, the energy delivery device further comprises atrocar or conical or other tissue-penetrating tip at its distal end. Insome embodiments, the tip is conductive. In some embodiments, the innerconductor is not electrically connected to the tip. In some embodiments,the inner conductor is capacitively coupled to the tip.

In some embodiments, the coolant flow exchanger comprise a cap having anopen proximal end forming an opening within the cap and a closed distalend. In some embodiments, the inner conductor is inserted into theopening in the cap. In some embodiments, the opening in the capcomprises one or more channels that return coolant from the innerconductor out of the open proximal end of the cap and into the air gap.

In some embodiments, the device has an outer diameter sized forendobronchial delivery of microwave energy to a central or peripherallung nodule (e.g., less than 3 mm, 2.8 mm, 2.5 mm, 2.3 mm, 2.1 mm, 2 mm,1.9 mm, 1.8 mm, 1.7 mm, 1.6 mm, 1.5 mm, 1.4 mm, etc.).

Further provided herein are systems comprising such an energy deliverydevice and one or more other components. Such systems may furthercomprise a delivery system for delivering the energy delivery devicefrom outside of the body to the target region inside of the body (e.g.,from a subject's mouth endobronchially or transbronchially to a centralor peripheral lung region). In some embodiments, the system comprises adelivery tube. In some embodiments, the delivery tube is conductive. Insome such embodiments, the delivery tube provides an outermost conductorthat forms a triaxial antenna with the outer and inner conductors of theenergy delivery device. In some embodiments, the delivery tube providean outer conductor and the energy delivery device includes only an innerconductor, the delivery device completing the coaxial antenna. In someembodiments, the system comprises a generator (e.g., a microwavegenerator). In some embodiments, the system comprises a coolant supply(e.g., a supply of pressurized gas such as CO₂). In some embodiments,the coolant supply delivers coolant through the inner conductor or otherpassageway at from zero to 1000 psi (e.g., 700 psi). In someembodiments, the system comprises a control computer that controls anydesired system components, including timing and amount of energy and/orcoolant delivery. In some embodiments, the system comprises an imagingdevice. In some embodiments, the system comprises an energy and coolantinterface to link the energy delivery device to power and coolantsupplies. In some embodiments, the interface comprises: a) a gasconnector for connecting to a coolant source; b) a power connector forconnecting to an electrical source; and c) an ablative power connectorfor connecting to a microwave generator.

Further provided herein are methods of using the energy delivery devicesor associated systems. In some embodiments, provided herein are methodsof ablating tissue comprising: positioning the distal end of an energydelivery device near a target tissue and applying ablative energy fromthe device. In some embodiments, the tissue is in a lung. In someembodiments, the energy delivery device is positioned endobronchially ortransbronchially. In some embodiments, the target tissue is a central orperipheral lung nodule. In some embodiments, the systems, devices, andmethods access lung nodules, tumors, and/or lesions on central orperipheral lung tissue (e.g. without entry into the lung by piercing thelung tissue). In some embodiments, the systems, devices, and methodsprovide access to lung nodules, tumors, and/or lesions on central orperipheral lung tissue through the trachea and/or bronchial tree (e.g.primary, secondary, and tertiary bronchia, and bronchioles). In someembodiments, the systems, devices, and methods deliver energy (e.g.microwave energy) through the bronchial tree to the central orperipheral lung without tissue damage (e.g. without significantlydamaging the tissue along the path).

The systems are not limited by the nature of the coolant materialemployed. Coolants included, but are not limited to, liquids and gases.Exemplary coolant fluids include, but are not limited to, one or more ofor combinations of, water, glycol, air, inert gasses, carbon dioxide,nitrogen, helium, sulfur hexafluoride, ionic solutions (e.g., sodiumchloride with or without potassium and other ions), dextrose in water,Ringer's lactate, organic chemical solutions (e.g., ethylene glycol,diethylene glycol, or propylene glycol), oils (e.g., mineral oils,silicone oils, fluorocarbon oils), liquid metals, freons, halomethanes,liquified propane, other haloalkanes, anhydrous ammonia, sulfur dioxide.In some embodiments, the coolant fluid also serves as the dielectricmaterial. In some embodiments, the coolant is a gas compressed at ornear its critical point. In some embodiments, cooling occurs, at leastin part, by changing concentrations of coolant, pressure, volume, ortemperature. For example, cooling can be achieved via gas coolants usingthe Joule-Thompson effect. In some embodiments, the cooling is providedby a chemical reaction. The devices are not limited to a particular typeof temperature reducing chemical reaction. In some embodiments, thetemperature reducing chemical reaction is an endothermic reaction. Insome embodiments, the coolant is a super-cooled gas. In someembodiments, cooling is controlled by a pressure control system. In someembodiments, cooling of a coolant employs a thermoelectric chiller(e.g., Peltier cooler, heat-exchanger, etc.).

In some embodiments, the energy delivery devices prevent undesiredheating and/or maintain desired energy delivery properties throughadjusting the amount of energy emitted from the device (e.g., adjustingthe energy wavelength resonating from the device) as temperaturesincrease. The devices are not limited to a particular method ofadjusting the amount of energy emitted from the device. In someembodiments, the devices are configured such that as the device reachesa certain threshold temperature or as the device heats over a range, theenergy wavelength resonating from the device is adjusted. The devicesare not limited to a particular method for adjusting energy wavelengthresonating from the device. In some embodiments, the energy deliverydevices prevent undesired heating and/or maintain desired energydelivery properties through adjusting the energy delivery programwithout adjusting (e.g., lowering) the energy wavelength. In someembodiments, pulsed programs deliver bursts of energy to the treatmentsite (e.g. bursts of energy sufficient to perform the desired task (e.g.ablation)) without inducing undesired heating along the transmissionpath. In some embodiments, pulsed programs reduce heat along thetransmission pathway when compared to continuous delivery programs. Insome embodiments, different patterns of pulse programs effectivelybalance the potentially conflicting desires of large amounts of energydelivered to the treatment site and reduced heat along the deliverypath. In some embodiments, different pulse patterns (e.g. length of timedelivering energy, length of time between energy pulses) and differentenergy levels (e.g. energy wavelengths) are utilized to optimizeenergy-delivery and path-heating.

In some embodiments, the energy delivery devices comprise a triaxialmicrowave probe with optimized tuning capabilities to reduce reflectiveheat loss (see, e.g., U.S. Pat. No. 7,101,369; see, also, U.S. patentapplication Ser. Nos. 10/834,802, 11/236,985, 11/237,136, 11,237,430,11/440,331, 11/452,637, 11/502,783, 11/514,628; and International PatentApplication No. PCT/US05/14534; herein incorporated by reference in itsentirety). In some embodiments, the energy delivery devices emit energythrough a coaxial transmission line (e.g., coaxial cable) having air orother gases as a dielectric core (see, e.g., U.S. patent applicationSer. No. 11/236,985; herein incorporated by reference in its entirety).

The control systems are not limited to a particular type of controlleror processor. In some embodiments, the processor is designed to, forexample, receive information from components of the system (e.g.,temperature monitoring system, energy delivery device, tissue impedancemonitoring component, etc.), display such information to a user, andmanipulate (e.g., control) other components of the system. In someembodiments, the processor is configured to operate within a systemcomprising an energy delivery device, a power supply, a means ofdirecting, controlling and delivering power (e.g., a power splitter), animaging system, a tuning system, and/or a temperature adjustment system.

The systems, devices, and methods are not limited to a particular typeof power supply. In some embodiments, the power supply is configured toprovide any desired type of energy (e.g., microwave energy,radiofrequency energy, radiation, cryo energy, electroporation, highintensity focused ultrasound, and/or mixtures thereof). In someembodiments, the power supply utilizes a power splitter to permitdelivery of energy to two or more energy delivery devices. In someembodiments, the power supply is configured to operate within a systemcomprising a power splitter, a processor, an energy delivery device, animaging system, a tuning system, and/or a temperature adjustment system.

The systems, devices, and methods are not limited to a particular typeof imaging system. In some embodiments, the imaging system utilizesimaging devices (e.g., endoscopic devices, stereotactic computerassisted neurosurgical navigation devices, thermal sensor positioningsystems, motion rate sensors, steering wire systems, intraproceduralultrasound, fluoroscopy, computerized tomography magnetic resonanceimaging, nuclear medicine imaging devices triangulation imaging,interstitial ultrasound, microwave imaging, acoustic tomography, dualenergy imaging, thermoacoustic imaging, infrared and/or laser imaging,electromagnetic imaging) (see, e.g., U.S. Pat. Nos. 6,817,976,6,577,903, and 5,697,949, 5,603,697, and International PatentApplication No. WO 06/005,579; each herein incorporated by reference intheir entireties). In some embodiments, the systems utilize endoscopiccameras, imaging components, and/or navigation systems that permit orassist in placement, positioning, and/or monitoring of any of the itemsused with the energy systems of the present invention. In someembodiments, the imaging system is configured to provide locationinformation of particular components of the energy delivery system(e.g., location of the energy delivery device). In some embodiments, theimaging system is configured to operate within a system comprising aprocessor, an energy delivery device, a power supply, a tuning system,and/or a temperature adjustment system. In some embodiments, the imagingsystem is located within the energy delivery device. In someembodiments, the imaging system provides qualitative information aboutthe ablation zone properties (e.g., the diameter, the length, thecross-sectional area, the volume). The imaging system is not limited toa particular technique for providing qualitative information. In someembodiments, techniques used to provide qualitative information include,but are not limited to, time-domain reflectometry, time-of-flight pulsedetection, frequency-modulated distance detection, eigenmode orresonance frequency detection or reflection and transmission at anyfrequency, based on one interstitial device alone or in cooperation withother interstitial devices or external devices. In some embodiments, theinterstitial device provides a signal and/or detection for imaging(e.g., electro-acoustic imaging, electromagnetic imaging, electricalimpedance tomography).

The systems, devices, and methods are not limited to a particular tuningsystem. In some embodiments, the tuning system is configured to permitadjustment of variables (e.g., amount of energy delivered, frequency ofenergy delivered, energy delivered to one or more of a plurality ofenergy devices that are provided in the system, amount of or type ofcoolant provided, etc.) within the energy delivery system. In someembodiments, the tuning system comprises a sensor that provides feedbackto the user or to a processor that monitors the function of an energydelivery device continuously or at time points. In some embodiments,reflected energy is monitored to assess energy delivery. The sensor mayrecord and/or report back any number of properties, including, but notlimited to, heat (e.g., temperature) at one or more positions of acomponent of the system, heat at the tissue, property of the tissue,qualitative information of the region, and the like. The sensor may bein the form of an imaging device such as CT, ultrasound, magneticresonance imaging, fluoroscopy, nuclear medicine imaging, or any otherimaging device. In some embodiments, particularly for researchapplication, the system records and stores the information for use infuture optimization of the system generally and/or for optimization ofenergy delivery under particular conditions (e.g., patient type, tissuetype, size and shape of target region, location of target region, etc.).In some embodiments, the tuning system is configured to operate within asystem comprising a processor, an energy delivery device, a powersupply, an imaging, and/or a temperature adjustment system. In someembodiments, the imaging or other control components provide feedback tothe ablation device so that the power output (or other controlparameter) can be adjusted to provide an optimum tissue response.

The systems, devices, and methods are not limited to a particulartemperature adjustment system. In some embodiments, the temperatureadjustment systems are designed to reduce unwanted heat of variouscomponents of the system (e.g., energy delivery devices) during medicalprocedures (e.g., tissue ablation) or keep the target tissue within acertain temperature range. In some embodiments, the temperatureadjustment systems are configured to operate within a system comprisinga processor, an energy delivery device, a power supply, components fordirecting, controlling and delivering power (e.g., a power splitter), atuning system, and/or an imaging system.

In some embodiments, the systems further comprise temperature monitoringor reflected power monitoring systems for monitoring the temperature orreflected power of various components of the system (e.g., energydelivery devices) and/or a tissue region. In some embodiments, themonitoring systems are designed to alter (e.g., prevent, reduce) thedelivery of energy to a particular tissue region if, for example, thetemperature or amount of reflected energy, exceeds a predeterminedvalue. In some embodiments, the temperature monitoring systems aredesigned to alter (e.g., increase, reduce, sustain) the delivery ofenergy to a particular tissue region so as to maintain the tissue orenergy delivery device at a preferred temperature or within a preferredtemperature range.

In some embodiments, the systems further comprise an identification ortracking system configured, for example, to prevent the use ofpreviously used components (e.g., non-sterile energy delivery devices),to identify the nature of a component of the system so the othercomponents of the system may be appropriately adjusted for compatibilityor optimized function. In some embodiments, the system reads a bar codeor other information-conveying element associated with a component ofthe systems of the invention. In some embodiments, the connectionsbetween components of the system are altered (e.g., broken) followinguse so as to prevent additional uses. The present invention is notlimited by the type of components used in the systems or the usesemployed. Indeed, the devices may be configured in any desired manner.Likewise, the systems and devices may be used in any application whereenergy is to be delivered. Such uses include any and all medical,veterinary, and research applications.

The systems, devices, and methods are not limited by the nature of thetarget tissue or region. Uses include, but are not limited to, treatmentof heart arrhythmia, tumor ablation (benign and malignant), control ofbleeding during surgery, after trauma, for any other control ofbleeding, removal of soft tissue, tissue resection and harvest,treatment of varicose veins, intraluminal tissue ablation (e.g., totreat esophageal pathologies such as Barrett's Esophagus and esophagealadenocarcinoma), treatment of bony tumors, normal bone, and benign bonyconditions, intraocular uses, uses in cosmetic surgery, treatment ofpathologies of the central nervous system including brain tumors andelectrical disturbances, sterilization procedures (e.g., ablation of thefallopian tubes) and cauterization of blood vessels or tissue for anypurposes. In some embodiments, the surgical application comprisesablation therapy (e.g., to achieve coagulative necrosis). In someembodiments, the surgical application comprises tumor ablation totarget, for example, metastatic tumors. In some embodiments, the deviceis configured for movement and positioning, with minimal damage to thetissue or organism, at any desired location, including but not limitedto, the brain, neck, chest, lung (e.g. central or peripheral lung),abdomen, and pelvis. In some embodiments, the systems are configured forguided delivery, for example, by computerized tomography, ultrasound,magnetic resonance imaging, fluoroscopy, and the like.

The systems, devices, and methods may be used in conjunction with othersystems, device, and methods. For example, the systems, devices, andmethods of the present invention may be used with other ablationdevices, other medical devices, diagnostic methods and reagents, imagingmethods and reagents, device placement systems, and therapeutic methodsand agents. Use may be concurrent or may occur before or after anotherintervention.

Additionally, integrated ablation and imaging systems are provided thatfeature feedback to a user and permit communication between varioussystem components. System parameters may be adjusted during the ablationto optimize energy delivery. In addition, the user is able to moreaccurately determine when the procedure is successfully completed,reducing the likelihood of unsuccessful treatments and/or treatmentrelated complications.

In some embodiments, the present invention provides devices, systems,and methods for placing energy delivery devices in difficult to reachstructures, tissue regions, and/or organs (e.g. a branched structure(e.g. human lungs). Accordingly, in some embodiments, the presentinvention provides a multiple-catheter system or device comprising: aprimary catheter, which comprises an inner lumen (the primary lumen); achannel catheter, or sheath, which comprises an inner lumen (channellumen), wherein the channel catheter is configured to fit within theprimary lumen; and one or more insertable tools (e.g. steerablenavigation catheter, therapeutic tools (e.g. energy delivery device,biopsy forceps, needles, etc.), etc.), wherein one or more insertabletools are configured to fit within the channel lumen. In someembodiments, the present invention provides a method for accessingdifficult to access tissue regions (e.g. highly branched tissue, e.g.periphery of the lungs) comprising: providing a steerable navigationcatheter within the channel lumen of a channel catheter, wherein thechannel catheter is within the primary lumen of a primary catheter. Insome embodiments, a steerable navigation catheter comprises: i) asteerable tip which allows manipulation of its position within apatient, organ, lumen, and/or tissue by a clinician or operator, and ii)a position sensor, which allows tracking of the steerable navigationcatheter through a patient, organ, lumen, and/or tissue. In someembodiments, a steerable tip of a steerable navigation catheterfunctions by pointing tip of the catheter in the desired direction ofmotion. In some embodiments, manual or automated movement of thecatheter results in movement directed in the direction of the tip. Insome embodiments, a primary catheter, channel catheter, and steerablenavigation catheter are inserted into a tissue region (e.g. bronchi)within a patient, and the primary catheter (e.g. bronchoscope) isinserted as far into the tissue region as the size of the availablespace (e.g. lumen (e.g. lumen of the brochia)) and the size of theprimary catheter (e.g. bronchoscope) will allow. In some embodiments,the primary catheter, channel catheter and steerable navigation catheterare moved through the patient, organ, lumen, and/or tissue via thesteerable tip of the steerable navigation catheter and/or steeringmechanisms within the primary catheter. In some embodiments, the channelcatheter and steerable navigation catheter are extended beyond the endof the primary catheter to access smaller, deeper, and/or more difficultto access tissue regions (e.g. central or peripheral bronchi,bronchioles, etc.). In some embodiments, the channel catheter andsteerable navigation catheter are moved through the patient, organ,lumen, and/or tissue via the steerable tip of the steerable navigationcatheter. In some embodiments, the position of the channel catheter andsteerable navigation catheter are monitored via the position sensor ofthe steerable navigation catheter. In some embodiments, the distal endsof the channel catheter and steerable navigation catheter are placed atthe target site (e.g. treatment site) in the patient, organ, lumen,and/or tissue (e.g. central or peripheral bronchi of the lung, centralor peripheral lung nodule, etc.). In some embodiments, upon properplacement of the distal ends of the channel catheter and steerablenavigation catheter at the target site (e.g. treatment site), thechannel catheter (e.g. distal end of the channel catheter) is securedinto position. In some embodiments, the distal end of the channelcatheter is secured in proper place using any suitable stabilizationmechanism (e.g. screws, clips, wings, etc.), as is understood in theart. In some embodiments, upon proper placement of the distal ends ofthe channel catheter and steerable navigation catheter at the targetsite (e.g. treatment site), the steerable navigation catheter iswithdrawn through the channel catheter and out the proximal end of thechannel catheter. In some embodiments, withdrawing the steerablecatheter from the proximal end of the channel catheter leaves thechannel catheter in place as a channel for accessing the target site(e.g. treatment site) with any suitable insertable tools (e.g.therapeutic tools (e.g. energy delivery device, biopsy device, etc.),etc.). In some embodiments, a properly positioned and secured channelcatheter with the steerable navigation catheter removed comprises aguide channel for accessing the target site (e.g. central or peripheralbronchi of the lung) with insertable tools (e.g. energy delivery device,biopsy device, etc.) from outside a subject's body. In some embodiments,one or more insertable tools (e.g. therapeutic tools (e.g. energydelivery device, biopsy device, etc.) are inserted through the vacantchannel catheter (e.g. guide channel) and the distal tip of theinsertable tool is placed at the target site (e.g. treatment site). Insome embodiments, an energy delivery device (e.g. microwave ablationdevice) is inserted through the vacant channel catheter (e.g. guidechannel) and the distal tip of the energy delivery device is placed atthe target site (e.g. treatment site). In some embodiments, energy (e.g.microwave energy) is delivered through the channel catheter via theinserted energy delivery device to deliver energy to the target site(e.g. to ablate tissue at the target site).

In some embodiments, the present invention provides a method forsteering a catheter through a branched structure to a target location,comprising: (a) providing a steerable navigation catheter, wherein thesteerable navigation catheter comprises a position sensor elementlocated near a distal tip of the catheter, the position sensor elementbeing part of a system measuring a position and a pointing direction ofthe tip of the catheter relative to a three-dimensional frame ofreference; (b) designating the target location relative to thethree-dimensional frame of reference; (c) advancing the catheter intothe branched structure; and (d) displaying a representation of at leastone parameter defined by a geometrical relation between the pointingdirection of the tip of the catheter and a direction from the tip of thecatheter towards the target location. In some embodiments, the steerablenavigation catheter resides in the lumen of a channel catheter. In someembodiments, the steerable navigation catheter directs the movement ofthe channel catheter by the above mechanism. In some embodiments, thesteerable navigation catheter and channel catheter reside in the lumenof a primary catheter (e.g. bronchoscope). In some embodiments, thesteerable navigation catheter directs the movement of the channelcatheter and primary catheter by the above mechanism. In someembodiments, a primary catheter has a separate direction control(steering) mechanism from the steerable navigation catheter.

In some embodiments, a representation of at least one parameter definedby a geometrical relation between (i) the pointing direction of the tipof the steerable navigation catheter and (ii) a direction from the tipof the steerable navigation catheter towards the target location isdisplayed (e.g. to provide users with information regarding the positionand/or direction of the steerable navigation catheter). In someembodiments, the at least one parameter includes an angular deviationbetween the pointing direction of the tip of the steerable navigationcatheter and a direction from the tip of the steerable navigationcatheter towards the target location. In some embodiments, the at leastone parameter includes a direction of deflection required to bring thepointing direction of the steerable navigation catheter into alignmentwith the target location. In some embodiments, the representation of atleast one parameter is displayed in the context of a representation of aview taken along the pointing direction of the tip of the steerablenavigation catheter. In some embodiments, the position sensor element ispart of a six-degrees-of-freedom position measuring system measuring theposition and attitude of the tip of the steerable navigation catheter inthree translational and three rotational degrees of freedom. In someembodiments, the steerable navigation catheter is further provided witha multi-directional steering mechanism configured for selectivelydeflecting a distal portion of the catheter in any one of at least threedifferent directions. In some embodiments, the steering mechanism iscontrolled by a user via a control device at the proximal end of thesteerable navigation catheter. In some embodiments, the steeringmechanism is controlled by a user via a remote control device. In someembodiments, a path traveled by the tip of the steerable navigationcatheter is monitored by use of the position sensor element and arepresentation of the path traveled is displayed together with a currentposition of the tip, the representation being projected as viewed fromat least one direction non-parallel to the pointing direction of thetip.

In some embodiments, the target location (e.g. treatment location (e.g.tumor)) is designated by: (a) designating a target location by use ofcomputerized tomography data of a subject; and (b) registering thecomputerized tomography data with the three-dimensional frame ofreference. In some embodiments, other mapping data (e.g. MRI, x-ray,PET, etc.) is substituted for computerized tomography data in anyembodiments of the present invention described herein. In someembodiments, the registering is performed by: (a) providing thesteerable catheter with a camera; (b) generating a camera view of eachof at least three distinctive features within the subject; (c)generating from the computerized tomography data a simulated view ofeach of the at least three distinctive features, each camera view and acorresponding one of the simulated views constituting a pair of similarviews; (d) allowing an operator to designate a reference point viewedwithin each of the camera views and a corresponding reference pointviewed within each corresponding simulated view; and (e) deriving fromthe designated reference points a best fit registration between thecomputerized tomography data and the three-dimensional frame ofreference. In some embodiments, an intended route through a subject(e.g. through a branched structure (e.g. a lung structure (e.g.bronchi)) within a subject) to a target location is designated by use ofthe computerized tomography data and a representation of the intendedroute is displayed together with a current position of the tip, therepresentation being projected as viewed from at least one directionnon-parallel to the pointing direction of the tip. In some embodiments:(a) a current position of the position sensor element is detected; (b) avirtual endoscopy image is generated from the computerized tomographydata corresponding to an image that would be viewed by a camera locatedin predefined spatial relationship and alignment relative to theposition sensor element; and (c) displaying the virtual endoscopy image.

In some embodiments, a catheter system of the present inventioncomprises a steerable navigation catheter and a channel catheter havinga lumen extending from a proximal insertion opening to a distal opening;and a guide element configured for insertion through the proximalopening of the sheath to an inserted position extending along the lumento the distal opening. In some embodiments, a channel catheter is asheath, through which a steerable navigation catheter (or an energydelivery device) can be inserted and/or withdrawn. In some embodiments,the steerable navigation catheter is used to position the channelcatheter such that the distal tips of the steerable navigation catheterand channel catheter are adjacent to the target location (e.g. treatmentsite (e.g. tumor)). In some embodiments, the channel catheter is lockedinto proper position at the target location. In some embodiments, thesteerable navigation catheter is withdrawn from the channel lumenleaving an open channel extending from the point of insertion into thesubject to the target site. In some embodiments, the channel catheter isavailable for insertion of an insertable tool (e.g. medical tool (e.g.energy delivery device). In some embodiments, the present inventionprovides a method comprising: (a) guiding a steerable navigationcatheter within a channel catheter to a position with the tip adjacentto the target location; and (b) withdrawing the steerable navigationcatheter from the channel catheter to leave the channel lumen availablefor insertion of a medical tool (e.g. energy delivery device).

In some embodiments, a catheter system provides a primary catheter (e.g.flexible endoscope, flexible bronchoscope, etc.) having an operationhandle and a primary lumen, a channel catheter deployed within theprimary lumen and having a channel lumen, and a steerable navigationcatheter deployed within the channel lumen. In some embodiments, thepresent invention provides a method comprising: inserting the primarycatheter, housing the channel catheter and steerable navigationcatheter, into a subject, organ, tissue, and/or lumen until the primarycatheter reaches its maximum insertion distance (e.g. limited by sizefrom further insertion; (b) locking the steerable navigation catheterwithin the channel lumen to prevent movement of the steerable navigationcatheter relative to the channel catheter; (c) guiding the steerablenavigation catheter and channel catheter beyond the distal end of theprimary catheter to the target location; (d) locking the channelcatheter within the primary lumen to prevent relative movement of thechannel catheter relative to the primary catheter and/or operationhandle; and (e) unlocking and withdrawing the steerable navigationelement from the channel catheter so as to leave the channel in place asa guide for inserting a tool (e.g. energy delivery device) to the targetlocation. In some embodiments, a system or device of the presentinvention comprises a stabilization and/or anchoring mechanism to holdone or more elements in place when deployed in a subject and/or bodyregion. In some embodiments, a selectively actuatable anchoringmechanism is associated with a portion of the channel catheter. In someembodiments, the selectively actuatable anchoring mechanism includes aninflatable element. In some embodiments, the selectively actuatableanchoring mechanism includes a mechanically deployed element. In someembodiments, a portion of the device is cooled sufficiently to freeze toneighboring tissue, creating a tissue lock (see e.g., U.S. Pat. No.9,119,649, herein incorporated by reference in its entirety).

In some embodiments, a channel catheter and/or steerable navigationcatheter includes an image sensor deployed for generating an image inthe pointing direction of the catheter. In some embodiments, the imagesensor is configured to be withdrawn with the steerable navigationcatheter.

In some embodiments, the present invention provides a method forachieving registration between computerized tomography data (or othermapping data, e.g., MRI, PET, X-ray, etc.) and a three dimensional frameof reference of a position measuring system, the method comprising: (a)providing a catheter with: (i) a position sensor element which operatesas part of the position measuring system to allow measurement of aposition and a pointing direction of the tip of the catheter relative tothe three-dimensional frame of reference, and (ii) an image sensor; (b)generating from the computerized tomography data at least threesimulated views of distinctive features within the branched structure;(c) generating at least three camera views of the distinctive features,each camera view and a corresponding one of the simulated viewsconstituting a pair of similar views; (d) allowing an operator todesignate a reference point viewed within each of the camera views and acorresponding reference point viewed within each corresponding simulatedview; and (e) deriving from the designated reference points a best fitregistration between the computerized tomography image and thethree-dimensional frame of reference. In some embodiments, designationof a reference point within each of the camera views by the operator isperformed by the operator bringing the position sensor element intoproximity with the reference point. In some embodiments, designation ofa reference point within each simulated view by the operator isperformed by: (a) the operator selecting a simulated image referencepoint within each simulated view; (b) calculating from the simulatedimage reference point a simulated-viewing-point-to-reference-pointvector; and (c) calculating a point of intersection between thesimulated-viewing-point-to-reference-point vector and a tissue surfacein a numerical model of a portion of the body derived from thecomputerized tomography data. In some embodiments: (a) at least onelocation within the computerized tomography data is identified; (b) aposition of the at least one location is calculated within thethree-dimensional frame of reference; and (c) a representation of the atleast one location is displayed together with a representation of aposition of the position sensor element. In some embodiments, the atleast one location includes a target location (e.g. treatment location(e.g. tumor, bronchi (e.g. central or peripheral bronchi), etc.)) towhich a medical tool (e.g. energy delivery device (e.g. microwaveablation device), etc.) is to be directed. In some embodiments, the atleast one location is a series of locations defining a planned pathalong which a medical tool is to be directed. In some embodiments, amethod for achieving registration between computerized tomography dataand a three dimensional frame of reference of a position measuringsystem, the method comprising: (a) providing a steerable navigationcatheter with: (i) a position sensor element which operates as part ofthe position measuring system to allow measurement of a position and apointing direction of the tip of the catheter relative to thethree-dimensional frame of reference, and (ii) an image sensor; (b)moving the tip of the catheter along a first branch portion of abranched structure and deriving a plurality of images from the camera,each image being associated with corresponding position data of theposition sensor in the three dimensional frame of reference; (c)processing the images and corresponding position data to derive abest-fit of a predefined geometrical model to the first branch portionin the three dimensional frame of reference; (d) repeating steps (b) and(c) for a second branch portion of the branched structure; and (e)correlating the geometrical models of the first and second branchportions with the computerized tomography data to derive a best fitregistration between the computerized tomography data and the threedimensional frame of reference. In some embodiments, the processing theimages and corresponding position data includes: (a) identifying visiblefeatures each of which is present in plural images taken at differentpositions; (b) for each of the visible features, deriving acamera-to-feature direction in each of a plurality of the images; (c)employing the camera-to-feature directions and corresponding positiondata to determine a feature position for each visible feature; and (d)deriving a best-fit of the predefined geometrical model to the featurepositions. In some embodiments, the predefined geometrical model is acylinder. In some embodiments: (a) at least one location within thecomputerized tomography data is identified; (b) a position of the atleast one location within the three-dimensional frame of reference iscalculated; and (c) a representation of the at least one location isdisplayed together with a representation of a position of the positionsensor element. In some embodiments, the at least one location includesa target location (e.g. treatment location (e.g. tumor (e.g. tumor inthe central or peripheral bronchi))) to which a medical tool (e.g.energy delivery device (e.g. microwave ablation device) is to bedirected. In some embodiments, the at least one location is a series oflocations defining a planned path along which a medical tool is to bedirected.

In some embodiments, the present invention provides a steering mechanismfor selectively deflecting a distal portion of a steerable navigationcatheter in any one of at least two independent directions, themechanism comprising: (a) at least three elongated tensioning elementsextending along the catheter and configured such that tension applied toany one of the tensioning elements causes deflection of a tip of thecatheter in a corresponding predefined direction; (b) an actuatordisplaceable from a first position to a second position; and (c) aselector mechanism configured for selectively mechanicallyinterconnecting a selected at least one of the elongated tensioningelements and the actuator such that displacement of the actuator fromthe first position to the second position applies tension to theselected at least one of the elongated tensioning elements. In someembodiments, a first state of the selector mechanism mechanicallyinterconnects a single one of the elongated tensioning elements with theactuator such that displacement of the actuator generates deflection ofthe tip in one of the predefined directions, and a second state of theselector mechanism mechanically interconnects two of the elongatedtensioning elements with the actuator such that displacement of theactuator generates deflection of the tip in an intermediate directionbetween two of the predefined directions. In some embodiments, the atleast three tensioning elements includes an even number of thetensioning elements, pairs of the tensioning elements being implementedas a single elongated element extending from the selector mechanismalong the catheter to the tip and back along the steerable navigationcatheter to the selector mechanism. In some embodiments, the at leastthree tensioning elements is implemented as four tensioning elementsdeployed such that each tensioning element, when actuated alone, causesdeflection of the tip in a different one of four predefined directionsseparated substantially by multiples of 90°. In some embodiments, afirst state of the selector mechanism mechanically interconnects asingle one of the elongated tensioning elements with the actuator suchthat displacement of the actuator generates deflection of the tip in oneof the four predefined directions, and a second state of the selectormechanism mechanically interconnects two of the elongated tensioningelements with the actuator such that displacement of the actuatorgenerates deflection of the tip in one of four intermediate directionseach lying between two of the four predefined directions. In someembodiments, the actuator includes a ring which is slidable relative toa handle associated with the catheter, and wherein the selectormechanism includes a slide attached to each of the tensioning elementsand slidably deployed within the handle and at least one projectionprojecting from the ring such that, when the ring is rotated, the atleast one projection selectively engages at least one of the slides suchthat displacement of the ring causes movement of the at least one slide.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a cross-sectional view of an energy delivery device withcoolant channels.

FIG. 2 shows a cutaway view of an energy delivery device with coolantchannels.

FIGS. 3A-C show a coolant flow reversal cap. FIG. 3A shows an externalview showing proximal opening. FIG. 3B shows a cutaway view. FIG. 3Cshows an external view of dimensions.

FIGS. 4A-B show an energy delivery device with coolant flow reversalcap. FIG. 4A shows a completed device. FIG. 4B shows a three steps inthe manufacture of the device in FIG. 4A.

FIG. 5 shows a cross-sectional view of an energy delivery device withcoolant channels, some of which are exterior to the outer conductor.

FIG. 6 shows a cross-sectional view of an energy delivery device with acoolant tube exterior to the outer conductor.

FIG. 7 shows an exemplary interface for connecting an energy deliverydevice to power and coolant sources.

DETAILED DESCRIPTION

The systems, devices, and methods provided herein provide comprehensivesystems, devices and methods for delivering energy (e.g., microwaveenergy) to tissue for a wide variety of applications, including medicalprocedures (e.g., tissue ablation (e.g. tumor ablation), resection,cautery, vascular thrombosis, intraluminal ablation of a hollow viscus,cardiac ablation for treatment of arrhythmias, electrosurgery, tissueharvest, cosmetic surgery, intraocular use, etc.). In particular,systems, devices, and methods are provided for treating a difficult toaccess tissue region (e.g., a central or peripheral lung tumor).

The energy delivery devices described herein may be combined withinvarious system/kit embodiments. For example, systems comprise one ormore of a generator, a power distribution system, components fordirecting, controlling and delivering power (e.g., a power splitter),device placement systems (e.g. multiple catheter system), along with anyone or more accessory component (e.g., surgical instruments, softwarefor assisting in procedure, processors, temperature monitoring devices,etc.).

The systems, devices, and methods may be used in any medical procedure(e.g., percutaneous or surgical) involving delivery of energy (e.g.,radiofrequency energy, microwave energy, laser, focused ultrasound,etc.) to a tissue region. The systems are not limited to treating aparticular type or kind of tissue region (e.g., brain, liver, heart,blood vessels, foot, lung, bone, etc.). For example, the systems of thepresent invention find use in ablating tumor regions (e.g. lung tumors(e.g. central or peripheral lung tumors)). Additional treatmentsinclude, but are not limited to, treatment of heart arrhythmia, tumorablation (benign and malignant), control of bleeding during surgery,after trauma, for any other control of bleeding, removal of soft tissue,tissue resection and harvest, treatment of varicose veins, intraluminaltissue ablation (e.g., to treat esophageal pathologies such as Barrett'sEsophagus and esophageal adenocarcinoma), treatment of bony tumors,normal bone, and benign bony conditions, intraocular uses, uses incosmetic surgery, treatment of pathologies of the central nervous systemincluding brain tumors and electrical disturbances, sterilizationprocedures (e.g., ablation of the fallopian tubes) and cauterization ofblood vessels or tissue for any purposes. In some embodiments, thesurgical application comprises ablation therapy (e.g., to achievecoagulative necrosis). In some embodiments, the surgical applicationcomprises tumor ablation to target, for example, primary or metastatictumors or central or peripheral lung nodules. In some embodiments, thesurgical application comprises the control of hemorrhage (e.g.electrocautery). In some embodiments, the surgical application comprisestissue cutting or removal. In some embodiments, the device is configuredfor movement and positioning, with minimal damage to the tissue ororganism, at any desired location, including but not limited to, thebrain, neck, chest, abdomen, pelvis, and extremities. In someembodiments, the device is configured for guided delivery, for example,by computerized tomography, ultrasound, magnetic resonance imaging,fluoroscopy, and the like. In some embodiments, the devices, systems,and methods place energy delivery devices in difficult to reachstructures, tissue regions, and/or organs (e.g. a branched structure(e.g. human lungs)).

Exemplary components of the energy delivery systems are described inmore detail in the following sections: I. Power Supply; II. Energydelivery devices; III. Processor; IV. Imaging Systems; V. TuningSystems; VI. Temperature Adjustment Systems; VII. IdentificationSystems; VIII. Temperature Monitoring Devices; IX. Procedure DeviceHubs; X. Uses, and XI. Device Placement Systems.

I. Power Supply

The energy utilized within the energy delivery systems is suppliedthrough a power supply. The technology is not limited to a particulartype or kind of power supply. In some embodiments, the power supply isconfigured to provide energy to one or more components of the energydelivery systems (e.g., energy delivery device). The power supply is notlimited to providing a particular type of energy (e.g., radiofrequencyenergy, microwave energy, radiation energy, laser, focused ultrasound,etc.). However, in some preferred embodiments, microwave energy isemployed. The power supply is not limited to providing particularamounts of energy or at a particular rate of delivery. In someembodiments, the power supply is configured to provide energy to anenergy delivery device for purposes of tissue ablation.

In some embodiments, the power supply is configured to provide anydesired type of energy (e.g., microwave energy, radiofrequency energy,radiation, cryo energy, electroporation, high intensity focusedultrasound, and/or mixtures thereof). In some embodiments, the type ofenergy provided with the power supply is microwave energy. In someembodiments, the power supply provides microwave energy to ablationdevices for purposes of tissue ablation. The use of microwave energy inthe ablation of tissue has numerous advantages. For example, microwaveshave a broad field of power density (e.g., approximately 2 cmsurrounding an antenna depending on the wavelength of the appliedenergy) with a correspondingly large zone of active heating, therebyallowing uniform tissue ablation both within a targeted zone and inperivascular regions (see, e.g., International Publication No. WO2006/004585; herein incorporated by reference in its entirety). Inaddition, microwave energy has the ability to ablate large or multiplezones of tissue using multiple probes with more rapid tissue heating.Microwave energy has an ability to penetrate tissue to create deeplesions with less surface heating. Energy delivery times are shorterthan with radiofrequency energy and probes can heat tissue sufficientlyto create an even and symmetrical lesion of predictable and controllabledepth. Microwave energy is generally safe when used near vessels. Also,microwaves do not rely on electrical conduction as it radiates throughtissue, fluid/blood, as well as air. Therefore, microwave energy can beused in tissue, lumens, lungs, and intravascularly.

In some embodiments, the power supply is an energy generator. In someembodiments, the generator is configured to provide as much as 100 wattsof microwave power of a frequency of from 915 MHz to 5.8 GHz, althoughthe present invention is not so limited. In some embodiments, aconventional magnetron of the type commonly used in microwave ovens ischosen as the generator. In some embodiments, a single-magnetron basedgenerator (e.g., with an ability to output 300 W through a singlechannel, or split into multiple channels) is utilized. It should beappreciated, however, that any other suitable microwave power source cansubstituted in its place. In some embodiments, the types of generatorsinclude, but are not limited to, those available from Cober-Muegge, LLC,Norwalk, Conn., USA, Sairem generators, and Gerling Applied Engineeringgenerators. In some embodiments, the generator has at leastapproximately 60 Watts available (e.g., 50, 55, 56, 57, 58, 59, 60, 61,62, 65, 70, 100, 500, 1000 Watts). For a higher-power operation, thegenerator is able to provide approximately 300 Watts (e.g., 200 Watts,280, 290, 300, 310, 320, 350, 400, 750 Watts). In some embodiments,wherein multiple antennas are used, the generator is able to provide asmuch energy as necessary (e.g., 400 Watts, 500, 750, 1000, 2000, 10,000Watts). In some embodiments, the generator comprises solid stateamplifier modules which can be operated separately and phase-controlled.In some embodiments, generator outputs are combined constructively toincrease total output power. In some embodiments, the power supplydistributes energy (e.g., collected from a generator) with a powerdistribution system. The present invention is not limited to aparticular power distribution system. In some embodiments, the powerdistribution system is configured to provide energy to an energydelivery device (e.g., a tissue ablation catheter) for purposes oftissue ablation. The power distribution system is not limited to aparticular manner of collecting energy from, for example, a generator.The power distribution system is not limited to a particular manner ofproviding energy to ablation devices. In some embodiments, the powerdistribution system is configured to transform the characteristicimpedance of the generator such that it matches the characteristicimpedance of an energy delivery device (e.g., a tissue ablationcatheter).

In some embodiments, the power distribution system is configured with avariable power splitter so as to provide varying energy levels todifferent regions of an energy delivery device or to different energydelivery devices (e.g., a tissue ablation catheter). In someembodiments, the power splitter is provided as a separate component ofthe system. In some embodiments, the power splitter is used to feedmultiple energy delivery devices with separate energy signals. In someembodiments, the power splitter electrically isolates the energydelivered to each energy delivery device so that, for example, if one ofthe devices experiences an increased load as a result of increasedtemperature deflection, the energy delivered to that unit is altered(e.g., reduced, stopped) while the energy delivered to alternate devicesis unchanged. The present invention is not limited to a particular typeor kind of power splitter. In some embodiments, the power splitter isdesigned by SM Electronics. In some embodiments, the power splitter isconfigured to receive energy from a power generator and provide energyto additional system components (e.g., energy delivery devices). In someembodiments the power splitter is able to connect with one or moreadditional system components. In some embodiments, the power splitter isconfigured to deliver variable amounts of energy to different regionswithin an energy delivery device for purposes of delivering variableamounts of energy from different regions of the device. In someembodiments, the power splitter is used to provide variable amounts ofenergy to multiple energy delivery devices for purposes of treating atissue region. In some embodiments, the power splitter is configured tooperate within a system comprising a processor, an energy deliverydevice, a temperature adjustment system, a power splitter, a tuningsystem, and/or an imaging system. In some embodiments, the powersplitter is able to handle maximum generator outputs plus, for example,25% (e.g., 20%, 30%, 50%). In some embodiments, the power splitter is a1000-watt-rated 2-4 channel power splitter.

In some embodiments, where multiple antennas are employed, the systemmay be configured to run them simultaneously or sequentially (e.g., withswitching). In some embodiments, the system is configured to phase thefields for constructive or destructive interference. Phasing may also beapplied to different elements within a single antenna. In someembodiments, switching is combined with phasing such that multipleantennas are simultaneously active, phase controlled, and then switchedto a new set of antennas (e.g., switching does not need to be fullysequential). In some embodiments, phase control is achieved precisely.In some embodiments, phase is adjusted continuously so as to move theareas of constructive or destructive interference in space and time. Insome embodiments, the phase is adjusted randomly. In some embodiments,random phase adjustment is performed by mechanical and/or magneticinterference.

II. Energy Delivery Devices

The energy delivery systems contemplate the use of any type of energydelivery device configured to deliver (e.g., emit) energy (e.g.,ablation device, surgical device, etc.) (see, e.g., U.S. Pat. Nos.9,119,649, 9,072,532, 8,672,932, 7,467,015, 7,101,369, 7,033,352,6,893,436, 6,878,147, 6,823,218, 6,817,999, 6,635,055, 6,471,696,6,383,182, 6,312,427, 6,287,302, 6,277,113, 6,251,128, 6,245,062,6,026,331, 6,016,811, 5,810,803, 5,800,494, 5,788,692, 5,405,346,4,494,539, U.S. patent application Ser. Nos. 11/728,460, 11/728,457,11/728,428, 11/237,136, 11/236,985, 10/980,699, 10/961,994, 10/961,761,10/834,802, 10/370,179, 09/847,181; Great Britain Patent ApplicationNos. 2,406,521, 2,388,039; European Patent No. 1395190; andInternational Patent Application Nos. WO2011/140087, WO 06/008481, WO06/002943, WO 05/034783, WO 04/112628, WO 04/033039, WO 04/026122, WO03/088858, WO 03/039385 WO 95/04385; each herein incorporated byreference in their entireties).

In some embodiments, antennae configured to emit energy comprise coaxialtransmission lines. The devices are not limited to particularconfigurations of coaxial transmission lines. Examples of coaxialtransmission lines include, but are not limited to, coaxial transmissionlines developed by Pasternack, Micro-coax, and SRC Cables. In someembodiments, the coaxial transmission line has an inner (i.e., center)conductor, a dielectric element, and an outer conductor (e.g., outershield). In some embodiments, the systems utilize antennae havingflexible coaxial transmission lines (e.g., for purposes of positioningaround, for example, pulmonary veins or through tubular structures)(see, e.g., U.S. Pat. Nos. 7,033,352, 6,893,436, 6,817,999, 6,251,128,5,810,803, 5,800,494; each herein incorporated by reference in theirentireties).

In some embodiments, the energy delivery devices have a triaxialtransmission line. In some embodiments, a triaxial microwave probedesign has an outermost conductor that allows improved tuning of theantenna to reduce reflected energy through the transmission line. Thisimproved tuning reduces heating of the transmission line allowing morepower to be applied to the tissue and/or a smaller transmission line(e.g. narrower) to be used. Further, the outer conductor may slide withrespect to the inner conductors to permit adjustment of the tuning tocorrect for effects of the tissue on the tuning. In some embodiments, adevice comprising first, second, and third conductors is sufficientlyflexible to navigate a winding path (e.g. through a branched structurewithin a subject (e.g. through the brachial tree)). In some embodiments,the first and second conductors may fit slidably within the thirdconductor.

In some embodiments, one or more components of a coaxial transmissionline or triaxial transmission line comprise a flexible and/orcollapsible material (e.g. biaxially-oriented polyethylene terephthalate(boPET) (e.g. MYLAR, MELINEX, HOSTAPHAN, etc.), etc.). In someembodiments, the outer conductor of the coaxial transmission line (orsecond (middle) conductor of a triaxial transmission line) comprises aflexible and/or collapsible material (e.g. boPET). In some embodiments,a component of a coaxial transmission line (e.g. outer conductor)comprises boPET coated in one or more films to provide desiredcharacteristics (e.g. electric conductivity, heat insulation, etc.). Insome embodiments, a collapsible outer conductor allows the transmissionline to adopt variable cross-sectional profile (e.g. variable diameter,variable shape, etc.). In some embodiments, a collapsible outerconductor encircles the inner conductor. In some embodiments, acollapsible outer conductor forms a closed sack around the innerconductor. In some embodiments, fluid (e.g. dielectric material, and/orcoolant) can be flowed through the collapsible outer conductor to adjustits variable cross-sectional profile. In some embodiments, a collapsibleouter conductor adopts a collapsed conformation when fluid is withdrawnfrom the area within the outer conductor, thereby decreasing thepressure within the outer conductor. In some embodiments, in a collapsedconformation the outer conductor displays a minimized cross-sectionalprofile. In some embodiments, in a collapsed conformation the outerconductor closely hugs the periphery of the inner conductor. In someembodiments, the collapsed conformation provides decreasedcross-sectional profile and/or increased flexibility to aid ininsertion, placement, and/or withdrawal of the coaxial transmissionline. In some embodiments, a collapsible outer conductor adopts anexpanded conformation when fluid is flowed into the area within theouter conductor, thereby increasing the pressure within the outerconductor. In some embodiments, in an expanded conformation the outerconductor displays a maximized cross-sectional profile. In someembodiments, in an expanded conformation the distance between the innerconductor and the outer conductor is maximized. In some embodiments, theexpanded conformation provides increased cross-sectional profile and/oroptimized conduction to aid in energy delivery along the coaxialtransmission line. In some embodiments, the expanded conformationprovides an increased volume of coolant along the coaxial transmissionline. In some embodiments, the collapsible outer conductor adopts anysuitable shape in the expanded conformation. In some embodiments, thecoaxial transmission line runs through a lumen, the shape of whichdictates the expanded shape of the collapsible outer conductor. In someembodiments, the collapsible outer conductor adopts any suitable shapein the collapsed conformation. In some embodiments, the shape orconfiguration of the dielectric material dictates the collapsed shape ofthe collapsible outer conductor. In some embodiments, a collapsibleouter conductor also comprises a coolant sheath, as described herein.

In some embodiments, the dielectric material core is shaped to provideto provide channels within the dielectric space (e.g. air channels,coolant channels, vacant channels, etc.). In some embodiments, channelsare completely or partially encompassed by the dielectric material. Insome embodiments, the dielectric material divides the dielectric spaceinto channels to create a “wagon wheel” conformation. In someembodiments, the dielectric material divides the dielectric space (e.g.the space between the inner and outer conductors) into 1 or morechannels (e.g. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more channels). In someembodiments, the channels within the dielectric space serve as coolantchannels. In some embodiments, the channels within the dielectric spacehouse coolant tubes. In some embodiments, a coolant tube within achannel delivers coolant along the transmission line, and a coolantchannel provides the return path, to the proximal end of thetransmission line. In some embodiments, a channel comprises multiplecoolant tubes (e.g. coolant and return). In some embodiment, channelsformed by the dielectric material comprise a non-metallic filler. Insome embodiments, non-metallic filler resides in the channels in thedistal region of the transmission line (e.g. beyond the end of the outerconductor).

In some embodiments, the energy delivery devices are provided with aproximal portion and a distal portion, wherein the distal portion isdetachable and provided in a variety of different configurations thatcan attach to a proximal portion. For example, in some embodiments, theproximal portion comprises a handle and an interface to other componentsof the system (e.g., power supply) and the distal portion comprises adetachable antenna having desired properties. A plurality of differentantenna configured for different uses may be provided and attached tothe handle unit for the appropriate indication.

In some embodiments, the energy delivery devices have therein protectionsensors designed to prevent undesired use of the energy deliverydevices. The energy delivery devices are not limited to a particulartype or kind of protection sensors. In some embodiments, the energydelivery devices have therein a temperature sensor designed to measurethe temperature of, for example, the energy delivery device and/or thetissue contacting the energy delivery device. In some embodiments, as atemperature reaches a certain level the sensor communicates a warning toa user via, for example, the processor. In some embodiments, the energydelivery devices have therein a skin contact sensor designed to detectcontact of the energy delivery device with skin (e.g., an exteriorsurface of the skin). In some embodiments, upon contact with undesiredskin, the skin contact sensor communicates a warning to a user via, forexample, the processor. In some embodiments, the energy delivery deviceshave therein an air contact sensor designed to detect contact of theenergy delivery device with ambient air (e.g., detection throughmeasurement of reflective power of electricity passing through thedevice). In some embodiments, upon contact with undesired air, the skincontact sensor communicates a warning to a user via, for example, theprocessor. In some embodiments, the sensors are designed to prevent useof the energy delivery device (e.g., by automatically reducing orpreventing power delivery) upon detection of an undesired occurrence(e.g., contact with skin, contact with air, undesired temperatureincrease/decrease). In some embodiments, the sensors communicate withthe processor such that the processor displays a notification (e.g., agreen light) in the absence of an undesired occurrence. In someembodiments, the sensors communicate with the processor such that theprocessor displays a notification (e.g., a red light) in the presence ofan undesired occurrence and identifies the undesired occurrence.

In some embodiments, the energy delivery devices are used above amanufacturer's recommended power rating. In some embodiments, coolingtechniques described herein are applied to permit higher power delivery.The present invention is not limited to a particular amount of powerincrease. In some embodiments, power ratings exceed manufacturer'srecommendation by 5× or more (e.g., 5×, 6×, 10×, 15×, 20×, etc.).

In some embodiments, the device further comprises an anchoring elementfor securing the antenna at a particular tissue region. The device isnot limited to a particular type of anchoring element. In someembodiments, the anchoring element is an inflatable balloon (e.g.,wherein inflation of the balloon secures the antenna at a particulartissue region). An additional advantage of utilizing an inflatableballoon as an anchoring element is the inhibition of blood flow or airflow to a particular region upon inflation of the balloon. Such air orblood flow inhibition is particularly useful in, for example, cardiacablation procedures and ablation procedures involving lung tissue,vascular tissue, and gastrointestinal tissue. In some embodiments, theanchoring element is an extension of the antenna designed to engage(e.g., latch onto) a particular tissue region. Further examples include,but are not limited to, the anchoring elements described in U.S. Pat.Nos. 6,364,876, and 5,741,249; each herein incorporated by reference intheir entireties. In some embodiments, the anchoring element has acirculating agent (e.g. a gas delivered at or near its critical point;CO₂) that freezes the interface between antenna and tissue therebysticking the antenna in place. In such embodiments, as the tissue meltsthe antenna remains secured to the tissue region due to tissuedesiccation.

In some embodiments, the devices are used in the ablation of a tissueregion having high amounts of air and/or blood flow (e.g., pulmonarytissue, cardiac tissue, gastrointestinal tissue, vascular tissue). Insome embodiments involving ablation of tissue regions having highamounts of air and/or blood flow, an element is further utilized forinhibiting the air and/or blood flow to that tissue region. The presentinvention is not limited to a particular air and/or blood flowinhibition element. In some embodiments, the device is combined with anendotracheal/endobronchial tube. In some embodiments, a balloon attachedwith the device may be inflated at the tissue region for purposes ofsecuring the device(s) within the desired tissue region, and inhibitingblood and/or air flow to the desired tissue region.

Thus, in some embodiments, the systems, devices, and methods of thepresent invention provide an ablation device coupled with a componentthat provides occlusion of a passageway (e.g., bronchial occlusion). Theocclusion component (e.g., inflatable balloon) may be directly mountedon the ablation system or may be used in combination with anothercomponent (e.g., an endotracheal or endobronchial tube) associated withthe system.

In some embodiments, the devices may be mounted onto additional medicalprocedure devices. For example, the devices may be mounted ontoendoscopes, intravascular catheters, bronchoscopes, or laproscopes. Insome embodiments, the devices are mounted onto steerable catheters. Insome embodiments, a flexible catheter is mounted on an endoscope,intravascular catheter or laparoscope. For example, the flexiblecatheter, in some embodiments, has multiple joints (e.g., like acentipede) that permits bending and steering as desired to navigate tothe desired location for treatment. In some embodiments, devices aredeployed through endoscopes, intravascular catheters, bronchoscopes, orlaproscopes.

In some embodiments, the energy delivery systems of the presentinvention utilize devices configured for delivery of microwave energywith an optimized characteristic impedance. Such devices are configuredto operate with a characteristic impedance of 50Ω or higher (e.g.,between 50 and 90Ω; e.g., 50, 55, 56, 57, 58, 59, 60, 61, 62, . . . 90Ω,preferably at 77Ω). However, in other embodiments (e.g., where a largerinner conductor is employed), characteristic impedance of less than 50Ωis employed. In some embodiments, optimized characteristic impedance isachieved through selection of (or absence of) an appropriate dielectricmaterial.

In some embodiments, the energy delivery device comprises an antennacomprising an inner conductor; and a conductive tip at a distal end ofsaid antenna; wherein the inner conductor is not physically coupled tosaid conductive tip (e.g., wherein the inner conductor iscapacitively-coupled to the conductive tip) (see e.g., U.S. Pat. Publ.No. 2013/0165915, herein incorporated by reference in its entirety). Insome embodiments, the antenna comprises a conductive outer conductorsurrounding at least a portion of the inner conductor. In someembodiments, the conductive tip comprises a trocar.

A cross-sectional view of an embodiment of an energy delivery deviceoptimized and tested for endobronchial or transbronchial delivery forablative energy to lung tissues is shown in FIG. 1. The outermost layeris jacket. The jacket is preferably heat sealed to minimize heattransfer from inside the energy delivery device to outside the deviceand any tissues contacted or in the vicinity thereof. The jacket may bemade of any desired material. In some embodiments, the jacket comprisespolyester.

The next layer inward is a shield (e.g., external conductor). The shieldassists in minimizing heat transfer from inside the energy deliverydevice to outside the device and any tissues contacted or in thevicinity thereof. The shield also provide an outer conductor or anintermediate conductor in a coaxial or triaxial transmission line. Theshield may be made of any desired material. In some embodiments, theshield comprises one or more electrically conductive materials, such asmetals. In some embodiments, the shield is copper. In some embodiments,the shield is plated copper. In some embodiments, the plating is silver.In some embodiments, the outer conductor is constructed of braided orjointed material to provide both strength and flexibility.

The next layer inward is a non-conducting core tube. The core tube maybe entirely a dielectric material. One or more channels may be presentin the material. In some embodiments, the core tube comprises a plastic.In some embodiments, the core tube comprises a fluoropolymer. In someembodiments, the fluoropolymer is a semi-crystalline fully-fluorinatedmelt processable fluoropolymer (e.g., MFA (Solvay)).

The next layer inward is an air gap containing a monofilament tubingseparating and spacing the core from an inner conductor. In someembodiments, a plurality of tubes are provided (e.g., two, three, four,etc.). In some embodiments, the tube or tubes are helically wrappedaround the inner conductor. The tubes may be made of any desiredmaterial, preferably non-conductive. In some embodiments, the tubes areplastic. In some embodiments, the tubes are perfluoroalkoxy alkane (PFA)tubes.

The next layer inward is an inner conductor. The inner conductor may bemade of any desired conductive material. In some embodiments, the innerconductor is copper. In some embodiments, the inner conductor isannealed copper. In some embodiments, the inner conductor is hollow,containing a passageway in its center that permits transfer of fluids(e.g., gaseous or liquid coolants) along the length of the innerconductor.

The absolute and relative dimensions of each layer may be selected asdesired. Preferably the outer diameter is sufficiently small to allowentry of the antenna into the small airways of the internal lung orother desired biological areas to be targeted. Exemplary dimensions areshown in FIG. 1 with the outer diameter measured at the outside of thejacket layer being 1.65 mm (+/−0.05 mm), the diameter at the outer edgeof the shield of 1.6 mm (+/−0.05 mm), the diameter at the outer edge ofthe core of 1.4 mm (+/−0.025 mm), and the diameter at the inner edge ofthe core of 1.0 mm (+/−0.025 mm). In some embodiments, the antenna orits individual layers are larger or smaller than those exemplified inFIG. 1 (e.g., 5%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, etc.).

FIG. 2 shows an exemplary energy delivery of FIG. 1 shown length-wisewith a cutaway view showing the internal components.

In some embodiments, the internal conductor terminates at its distal endwith a coolant flow exchanger in the form of a gas return pin. The pinhas a proximal end with an opening and a closed distal end. The openingat the proximal end is sized to receive the inner conductor. The openingis further sized to provide one or more channels that are exterior to aninner conductor inserted into the opening. The outer diameter of the pinis sized to fit within the core. The hollow inner conductor terminateswithin the pin such that coolant flowing out of the distal end of theinternal conductor enters the opening within the pin, and is returnedthrough the one or more channels towards the proximal end of the pin.Coolant emerging out of the channels moves into the air space betweenthe inner conductor and the core. The presence of the monofilamenttubing in the this region creates one or more channels (e.g., a spiralchannel) along the length of the energy delivery device, provide a largesurface area for the coolant as it moves distal to proximal along theenergy delivery device. In some embodiments, the coolant path isreversed, initially traveling proximal to distal along the air gapbetween the inner conductor and core and reversed in the cap into thehollow pathway of the inner conductor where it returns distal toproximal along the energy delivery device. The cap may be made of anydesired material and may be conductive or non-conductive. In someembodiments, the cap is made of brass. An exemplary cap 100 is shown inFIGS. 3A-D. FIG. 3A shows an exterior view of a cap with a roundeddistal tip 110. The interior of the cap comprises four ridges 120 thatspan the length of the interior of the cap. The ridges create fourcoolant return channels 130 when an inner conductor is inserted into thecap. FIG. 3B shows an interior cut-away structure of the cap having ahollow inner conductor 200 inserted therein. The interior of the capcomprises a stop 140 to position the distal end of the inner conductor.In some embodiments, the stop is non-conductive to prevent electricalflow from the inner conductor to the cap. In some embodiments, the stopis conductive, allowing electrical flow from the inner conductor to thecap. Exemplary dimensions in mm and inches (in brackets) are provided.FIG. 3C shows exemplary dimensions of the exterior of the cap.

FIG. 4A shows a cutaway view of an energy delivery device with a capinserted therein. FIG. 4B shows an exemplary manufacturing process forinserting the cap. The top panel shows an energy delivery deviceterminating at the inner conductor. The middle panel shows insertion ofthe cap over the inner conductor with its distal end extending beyondthe end of the energy delivery device (1 mm in this example). The lowerpanel shows addition of material to form the exterior tip of energydelivery device. The formed round tip of the energy delivery device isshown in FIG. 4A. In some embodiments, a trocar or othertissue-penetrating tip is attached over the round tip (not shown).

A variety of alternative coolant management systems may be used. FIG. 5shows one example providing a cross-sectional view of an energy deliverydevice. In this embodiment, the inner conductor 500 is solid rather thanhollow. A core 510 creates an air space 520 between the core and theinner conductor 500. A monofilament tube 530 spiraled around the innerconductor within the air space adapts the air space 520 as a spiralchannel. An outer conductor 540 is exterior to the core 520. In thisdesign, an outer jacket 550 is provided around the outer conductor. Theouter jacket may be made of non-conductive insulating material or may beconductive (forming a triaxial antenna with the outer conductor andinner conductor). An air gap 560 is created between the outer jacket andthe outer conductor. The air gap 560 is transformed into a plurality ofchannels by the addition of spacer tubing 570. In some such embodiments,coolant is flowed proximal to distal along the air gap 520. Coolant isreturned distal to proximal via the air gap 560.

Another embodiment is shown in FIG. 6. In this embodiment, a gas inlettube 600 is provided between the outer conductor and the outer jacket.Coolant is flowed proximal to distal through the gas inlet tube 600 andreturned in the air space between the inner conductor and the core.

III. Processor

In some embodiments, the energy delivery systems utilize processors thatmonitor and/or control and/or provide feedback concerning one or more ofthe components of the system. In some embodiments, the processor isprovided within a computer module. The computer module may also comprisesoftware that is used by the processor to carry out one or more of itsfunctions. For example, in some embodiments, the systems providesoftware for regulating the amount of microwave energy provided to atissue region through monitoring one or more characteristics of thetissue region including, but not limited to, the size and shape of atarget tissue, the temperature of the tissue region, and the like (e.g.,through a feedback system) (see, e.g., U.S. patent application Ser. Nos.11/728,460, 11/728,457, and 11/728,428; each of which is hereinincorporated by reference in their entireties). In some embodiments, thesoftware is configured to provide information (e.g., monitoringinformation) in real time. In some embodiments, the software isconfigured to interact with the energy delivery systems such that it isable to raise or lower (e.g., tune) the amount of energy delivered to atissue region. In some embodiments, the software is designed to primecoolants for distribution into, for example, an energy delivery devicesuch that the coolant is at a desired temperature prior to use of theenergy delivery device. In some embodiments, the type of tissue beingtreated (e.g., lung) is inputted into the software for purposes ofallowing the processor to regulate (e.g., tune) the delivery ofmicrowave energy to the tissue region based upon pre-calibrated methodsfor that particular type of tissue region. In other embodiments, theprocessor generates a chart or diagram based upon a particular type oftissue region displaying characteristics useful to a user of the system.In some embodiments, the processor provides energy delivering algorithmsfor purposes of, for example, slowly ramping power to avoid tissuecracking due to rapid out-gassing created by high temperatures. In someembodiments, the processor allows a user to choose power, duration oftreatment, different treatment algorithms for different tissue types,simultaneous application of power to the antennas in multiple antennamode, switched power delivery between antennas, coherent and incoherentphasing, etc. In some embodiments, the processor is configured for thecreation of a database of information (e.g., required energy levels,duration of treatment for a tissue region based on particular patientcharacteristics) pertaining to ablation treatments for a particulartissue region based upon previous treatments with similar or dissimilarpatient characteristics. In some embodiments, the processor is operatedby remote control.

In some embodiments, the processor is used to generate, for example, anablation chart based upon entry of tissue characteristics (e.g., tumortype, tumor size, tumor location, surrounding vascular information,blood flow information, etc.). In such embodiments, the processordirects placement of the energy delivery device so as to achieve desiredablation based upon the ablation chart. In some embodiments, a processorcommunicates with positions sensors and/or steering mechanisms toprovide appropriate placement of systems and devices.

In some embodiments a software package (e.g., embodied in any desiredform of non-transitory computer readable media) is provided to interactwith the processor that allows the user to input parameters of thetissue to be treated (e.g., type of tumor or tissue section to beablated, size, where it is located, location of vessels or vulnerablestructures, and blood flow information) and then draw the desiredablation zone on a CT or other image to provide the desired results. Theprobes may be placed into the tissue, and the computer generates theexpected ablation zone based on the information provided. Such anapplication may incorporate feedback. For example, CT, MRI, orultrasound imaging or thermometry may be used during the ablation. Thisdata is fed back into the computer, and the parameters readjusted toproduce the desired result.

As used herein, the terms “computer memory” and “computer memory device”refer to any storage media readable by a computer processor. Examples ofcomputer memory include, but are not limited to, random access memory(RAM), read-only memory (ROM), computer chips, optical discs (e.g.,compact discs (CDs), digital video discs (DVDs), etc.), magnetic disks(e.g., hard disk drives (HDDs), floppy disks, ZIP® disks, etc.),magnetic tape, and solid state storage devices (e.g., memory cards,“flash” media, etc.).

As used herein, the term “computer readable medium” refers to any deviceor system for storing and providing information (e.g., data andinstructions) to a computer processor. Examples of computer readablemedia include, but are not limited to, optical discs, magnetic disks,magnetic tape, solid-state media, and servers for streaming media overnetworks.

As used herein, the terms “processor” and “central processing unit” or“CPU” are used interchangeably and refer to a device that is able toread a program from a computer memory device (e.g., ROM or othercomputer memory) and perform a set of steps according to the program.

IV. Imaging Systems

In some embodiments, the energy delivery systems utilize imaging systemscomprising imaging devices and/or software. The energy delivery systemsare not limited to particular types of imaging devices (e.g., endoscopicdevices, stereotactic computer assisted neurosurgical navigationdevices, thermal sensor positioning systems, motion rate sensors,steering wire systems, intraprocedural ultrasound, interstitialultrasound, microwave imaging, acoustic tomography, dual energy imaging,fluoroscopy, computerized tomography magnetic resonance imaging, nuclearmedicine imaging devices triangulation imaging, thermoacoustic imaging,infrared and/or laser imaging, electromagnetic imaging) (see, e.g., U.S.Pat. Nos. 6,817,976, 6,577,903, and 5,697,949, 5,603,697, andInternational Patent Application No. WO 06/005,579; each hereinincorporated by reference in their entireties). In some embodiments, thesystems utilize endoscopic cameras, imaging components, and/ornavigation systems that permit or assist in placement, positioning,and/or monitoring of any of the items used with the energy systems ofthe present invention.

In some embodiments, the energy delivery systems provide software isconfigured for use of imaging equipment (e.g., CT, MM, ultrasound). Insome embodiments, the imaging equipment software allows a user to makepredictions based upon known thermodynamic and electrical properties oftissue, vasculature, and location of the antenna(s). In someembodiments, the imaging software allows the generation of athree-dimensional map of the location of a tissue region (e.g., tumor,arrhythmia), location of the antenna(s), and to generate a predicted mapof the ablation zone.

In some embodiments, the imaging systems are used to monitor ablationprocedures (e.g., microwave thermal ablation procedures, radio-frequencythermal ablation procedures). The present invention is not limited to aparticular type of monitoring. In some embodiments, the imaging systemsare used to monitor the amount of ablation occurring within a particulartissue region(s) undergoing a thermal ablation procedure. In someembodiments, the monitoring operates along with the ablation devices(e.g., energy delivery devices) such that the amount of energy deliveredto a particular tissue region is dependent upon the imaging of thetissue region. The imaging systems are not limited to a particular typeof monitoring. The present invention is not limited to what is beingmonitored with the imaging devices. In some embodiments, the monitoringis imaging blood perfusion for a particular region so as to detectchanges in the region, for example, before, during and after a thermalablation procedure. In some embodiments, the monitoring includes, but isnot limited to, MRI imaging, CT imaging, ultrasound imaging, nuclearmedicine imaging, and fluoroscopy imaging. For example, in someembodiments, prior to a thermal ablation procedure, a contrast agent(e.g., iodine or other suitable CT contrast agent; gadolinium chelate orother suitable MRI contrast agent, microbubbles or other suitableultrasound contrast agent, etc.) is supplied to a subject (e.g., apatient) and the contrast agent perfusing through a particular tissueregion that is undergoing the ablation procedure is monitored for bloodperfusion changes. In some embodiments, the monitoring is qualitativeinformation about the ablation zone properties (e.g., the diameter, thelength, the cross-sectional area, the volume). The imaging system is notlimited to a particular technique for monitoring qualitativeinformation. In some embodiments, techniques used to monitor qualitativeinformation include, but are not limited to, non-imaging techniques(e.g., time-domain reflectometry, time-of-flight pulse detection,frequency-modulated distance detection, eigenmode or resonance frequencydetection or reflection and transmission at any frequency, based on oneinterstitial device alone or in cooperation with other interstitialdevices or external devices). In some embodiments, the interstitialdevice provides a signal and/or detection for imaging (e.g.,electro-acoustic imaging, electromagnetic imaging, electrical impedancetomography). In some embodiments, non-imaging techniques are used tomonitor the dielectric properties of the medium surrounding the antenna,detect an interface between the ablated region and normal tissue throughseveral means, including resonance frequency detection, reflectometry ordistance-finding techniques, power reflection/transmission frominterstitial antennas or external antennas, etc. In some embodiments,the qualitative information is an estimate of ablation status, powerdelivery status, and/or simple go/no-go checks to ensure power is beingapplied. In some embodiments, the imaging systems are designed toautomatically monitor a particular tissue region at any desiredfrequency (e.g., per second intervals, per one-minute intervals, perten-minute intervals, per hour-intervals, etc.). In some embodiments,the present invention provides software designed to automatically obtainimages of a tissue region (e.g., MRI imaging, CT imaging, ultrasoundimaging, nuclear medicine imaging, fluoroscopy imaging), automaticallydetect any changes in the tissue region (e.g., blood perfusion,temperature, amount of necrotic tissue, etc.), and based on thedetection to automatically adjust the amount of energy delivered to thetissue region through the energy delivery devices. Likewise, analgorithm may be applied to predict the shape and size of the tissueregion to be ablated (e.g., tumor shape) such that the system recommendsthe type, number, and location of ablation probes to effectively treatthe region. In some embodiments, the system is configured to with anavigation or guidance system (e.g., employing triangulation or otherpositioning routines) to assist in or direct the placement of the probesand their use.

For example, such procedures may use the enhancement or lack ofenhancement of a contrast material bolus to track the progress of anablation or other treatment procedure. Subtraction methods may also beused (e.g., similar to those used for digital subtraction angiography).For example, a first image may be taken at a first time point.Subsequent images subtract out some or all of the information from thefirst image so that changes in tissue are more readily observed.Likewise, accelerated imaging techniques may be used that apply “undersampling” techniques (in contrast to Nyquist sampling). It iscontemplated that such techniques provide excellent signal-to-noiseusing multiple low resolutions images obtained over time. For example,an algorithm called HYPER (highly constrained projection reconstruction)is available for MRI that may be applied to embodiments of the systemsof the invention.

As thermal-based treatments coagulate blood vessels when tissuetemperatures exceed, for example, 50° C., the coagulation decreasesblood supply to the area that has been completely coagulated. Tissueregions that are coagulated do not enhance after the administration ofcontrast. In some embodiments, the present invention utilizes theimaging systems to automatically track the progress of an ablationprocedure by giving, for example, a small test injection of contrast todetermine the contrast arrival time at the tissue region in question andto establish baseline enhancement. In some embodiments, a series ofsmall contrast injections is next performed following commencement ofthe ablation procedure (e.g., in the case of CT, a series of up tofifteen 10 ml boluses of 300 mgI/ml water soluble contrast is injected),scans are performed at a desired appropriate post-injection time (e.g.,as determined from the test injection), and the contrast enhancement ofthe targeted area is determined using, for example, a region-of-interest(ROI) to track any one of a number of parameters including, but notlimited to, attenuation (Hounsfield Units [HU]) for CT, signal (MM),echogenicity (ultrasound), etc. The imaged data is not limited to aparticular manner of presentation. In some embodiments, the imaging datais presented as color-coded or grey scale maps or overlays of the changein attenuation/signal/echogenicity, the difference between targeted andnon-targeted tissue, differences in arrival time of the contrast bolusduring treatment, changes in tissue perfusion, and any other tissueproperties that can be measured before and after the injection ofcontrast material. The methods of the present invention are not limitedto selected ROI's, but can be generalized to all pixels within anyimage. The pixels can be color-coded, or an overlay used to demonstratewhere tissue changes have occurred and are occurring. The pixels canchange colors (or other properties) as the tissue property changes, thusgiving a near real-time display of the progress of the treatment. Thismethod can also be generalized to 3d/4d methods of image display.

In some embodiments, the area to be treated is presented on a computeroverlay, and a second overlay in a different color or shading yields anear real-time display of the progress of the treatment. In someembodiments, the presentation and imaging is automated so that there isa feedback loop to a treatment technology (RF, MW, HIFU, laser, cryo,etc) to modulate the power (or any other control parameter) based on theimaging findings. For example, if the perfusion to a targeted area isdecreased to a target level, the power could be decreased or stopped.For example, such embodiments are applicable to a multiple applicatorsystem as the power/time/frequency/duty cycle, etc. is modulated foreach individual applicator or element in a phased array system to createa precisely sculpted zone of tissue treatment. Conversely, in someembodiments, the methods are used to select an area that is not to betreated (e.g., vulnerable structures that need to be avoided such asbile ducts, bowel, etc.). In such embodiments, the methods monitortissue changes in the area to be avoided, and warn the user (e.g.,treating physician) using alarms (e.g., visible and/or audible alarms)that the structure to be preserved is in danger of damage. In someembodiments, the feedback loop is used to modify power or any otherparameter to avoid continued damage to a tissue region selected not tobe treated. In some embodiments, protection of a tissue region fromablation is accomplished by setting a threshold value such as a targetROI in a vulnerable area, or using a computer overlay to define a “notreatment” zone as desired by the user.

V. Tuning Systems

In some embodiments, the energy delivery systems utilize tuning elementsfor adjusting the amount of energy delivered to the tissue region. Insome embodiments, the tuning element is manually adjusted by a user ofthe system. In some embodiments, a tuning system is incorporated into anenergy delivery device so as to permit a user to adjust the energydelivery of the device as desired (see, e.g., U.S. Pat. Nos. 5,957,969,5,405,346; each herein incorporated by reference in their entireties).In some embodiments, the device is pretuned to the desired tissue and isfixed throughout the procedure. In some embodiments, the tuning systemis designed to match impedance between a generator and an energydelivery device (see, e.g., U.S. Pat. No. 5,364,392; herein incorporatedby reference in its entirety). In some embodiments, the tuning elementis automatically adjusted and controlled by a processor. In someembodiments, a processor adjusts the energy delivery over time toprovide constant energy throughout a procedure, taking into account anynumber of desired factors including, but not limited to, heat, natureand/or location of target tissue, size of lesion desired, length oftreatment time, proximity to sensitive organ areas or blood vessels, andthe like. In some embodiments, the system comprises a sensor thatprovides feedback to the user or to a processor that monitors thefunction of the device continuously or at time points. The sensor mayrecord and/or report back any number of properties, including, but notlimited to, heat at one or more positions of a components of the system,heat at the tissue, property of the tissue, and the like. The sensor maybe in the form of an imaging device such as CT, ultrasound, magneticresonance imaging, or any other imaging device. In some embodiments,particularly for research application, the system records and stores theinformation for use in future optimization of the system generallyand/or for optimization of energy delivery under particular conditions(e.g., patient type, tissue type, size and shape of target region,location of target region, etc.).

VI. Temperature Adjustment Systems

In some embodiments, the energy delivery systems utilize coolant systemsso as to reduce undesired heating within and along an energy deliverydevice (e.g., tissue ablation catheter). The systems are not limited toa particular cooling system mechanism. In some embodiments, the systemsare designed to circulate a coolant (e.g., air, liquid, etc.) throughoutan energy delivery device such that the coaxial transmission line(s) ortriaxial transmission line(s) and antenna(e) temperatures are reduced.

In some embodiments, energy delivery devices utilize reduced temperatureenergy patterns to reduce undesired heating along the length of thetransmission line. In some embodiments, constant low power energytransmission provides sufficient energy at the target site (e.g.sufficient for effective tumor ablation) without undue heating along thepath of the transmission line. In some embodiments, energy is deliveredin a pulse pattern to provide bursts of sufficient energy at the targetsite (e.g. sufficient for effective tumor ablation) with less heatbuild-up along the transmission line than continuous delivery. In someembodiments, the length and intensity of the pulse-pattern are set bymonitoring temperature along the transmission line or in the tissuesurrounding the transmission line. In some embodiments, a pulse patternis predetermined to balance the amount of energy delivered to the targetsite with the amount of heat release along the transmission line. Insome embodiments, any suitable pulse pattern will find use with thedevices, systems, and methods of the present invention. In someembodiments, an ablation algorithm is calculated or determined based ona combination of time (e.g. of treatment, of pulses, of time betweenpulses), power (e.g. power generated, power delivered, power lost,etc.), and temperature monitoring.

In some embodiments, the flow of coolant is monitored to assess andcontrol temperature. For example, the pressure of coolant exhaustthrough a fixed sized chamber may be monitored. By measuring the in-flowand out-flow differential, coolant performance can be assessed. Shouldany parameter fall out of an acceptable performance range, an alarm maybe sounded and the system controls altered as desired (emergency off,etc.).

In some embodiments, an energy delivery device comprises a capacitorand/or energy gate at the distal end of the transmission line. Thecapacitor and/or gate delivers energy (e.g. microwave energy) to thetarget site once a threshold of energy has built up behind the capacitorand/or gate. Low level energy is delivered along the transmission line,thereby reducing heat build-up along the pathway. Once sufficient energyhas built up at the capacitor and/or gate, a high energy burst of energy(e.g. microwave energy) is delivered to the target site. The capacitorand/or gate delivery method has the advantage of reduced heating alongthe transmission path due to the low level energy transfer, as well asbursts of high energy being delivered at the target site (e.g.sufficient for tumor ablation).

In some embodiments, all or a portion of the energy generating circuitryis located at one or more points along the transmission line. In someembodiments, all or a portion of the microwave generating circuitry islocated at one or more points along the transmission line. In someembodiments, generating energy (e.g. microwave energy) at one or morepoints along the transmission line reduces the distance the energy needsto travel, thereby reducing energy loss, and undesired heat generation.In some embodiments, generating energy (e.g. microwave energy) at one ormore points along the transmission line allows for operating at reducedenergy levels while providing the same energy level to the treatmentsite.

VII. Identification Systems

In some embodiments, the energy delivery systems utilize identificationelements (e.g., RFID elements, identification rings (e.g., fidicials),barcodes, etc.) associated with one or more components of the system. Insome embodiments, the identification element conveys information about aparticular component of the system. The present invention is not limitedby the information conveyed. In some embodiments, the informationconveyed includes, but is not limited to, the type of component (e.g.,manufacturer, size, energy rating, tissue configuration, etc.), whetherthe component has been used before (e.g., so as to ensure thatnon-sterile components are not used), the location of the component,patient-specific information and the like. In some embodiments, theinformation is read by a processor of the present invention. In somesuch embodiments, the processor configures other components of thesystem for use with, or for optimal use with, the component containingthe identification element.

In some embodiments, the energy delivery devices have thereon markings(e.g., scratches, color schemes, etchings, painted contrast agentmarkings, radiopaque bands, identification rings (e.g., fidicials),and/or ridges) so as to improve identification of a particular energydelivery device (e.g., improve identification of a particular devicelocated in the vicinity of other devices with similar appearances). Themarkings find particular use where multiple devices are inserted into apatient. In such cases, particularly where the devices may cross eachother at various angles, it is difficult for the treating physician toassociate which proximal end of the device, located outside of thepatient body, corresponds to which distal end of the device, locatedinside the patient body. In some embodiments, a marking (e.g., a number)a present on the proximal end of the device so that it is viewable bythe physician's eyes and a second marking (e.g., that corresponds to thenumber) is present on the distal end of the device so that it isviewable by an imaging device when present in the body. In someembodiments, where a set of antennas is employed, the individual membersof the set are numbered (e.g., 1, 2, 3, 4, etc.) on both the proximaland distal ends. In some embodiments, handles are numbered, a matchingnumbered detachable (e.g., disposable) antennas are connected to thehandles prior to use. In some embodiments, a processor of the systemensures that the handles and antennas are properly matched (e.g., byRFID tag or other means). In some embodiments, where the antenna aredisposable, the system provides a warning if a disposable component isattempted to be re-used, when it should have been discarded. In someembodiments, the markings improve identification in any type ofdetection system including, but not limited to, MRI, CT, and ultrasounddetection.

The energy delivery systems of the present invention are not limited toparticular types of tracking devices. In some embodiments, GPS and GPSrelated devices are used. In some embodiments, RFID and RFID relateddevices are used. In some embodiments, barcodes are used.

In such embodiments, authorization (e.g., entry of a code, scanning of abarcode) prior to use of a device with an identification element isrequired prior to the use of such a device. In some embodiments, theinformation element identifies that a components has been used beforeand sends information to the processor to lock (e.g. block) use ofsystem until a new, sterile component is provided.

VIII. Temperature Monitoring Systems

In some embodiments, the energy delivering systems utilize temperaturemonitoring systems. In some embodiments, temperature monitoring systemsare used to monitor the temperature of an energy delivery device (e.g.,with a temperature sensor). In some embodiments, temperature monitoringsystems are used to monitor the temperature of a tissue region (e.g.,tissue being treated, surrounding tissue). In some embodiments, thetemperature monitoring systems are designed to communicate with aprocessor for purposes of providing temperature information to a user orto the processor to allow the processor to adjust the systemappropriately. In some embodiments, temperatures are monitored atseveral points along the antenna to estimate ablation status, coolingstatus or safety checks. In some embodiments, the temperatures monitoredat several points along the antenna are used to determine, for example,the geographical characteristics of the ablation zone (e.g., diameter,depth, length, density, width, etc.) (e.g., based upon the tissue type,and the amount of power used in the energy delivery device). In someembodiments, the temperatures monitored at several points along theantenna are used to determine, for example, the status of the procedure(e.g., the end of the procedure). In some embodiments, temperature ismonitored using thermocouples or electromagnetic means through theinterstitial antenna. In some embodiments, data collected fromtemperature monitoring is used to initiate one or more coolingprocedures described herein (e.g. coolant flow, lowered power, pulseprogram, shutoff, etc.).

IX. Procedure Device Hubs

The system may further employ one or more additional components thateither directly or indirectly take advantage of or assist the featuresof other components. For example, in some embodiments, one or moremonitoring devices are used to monitor and/or report the function of anyone or more components of the system. Additionally, any medical deviceor system that might be used, directly or indirectly, in conjunctionwith the devices may be included with the system. Such componentsinclude, but are not limited to, sterilization systems, devices, andcomponents, other surgical, diagnostic, or monitoring devices orsystems, computer equipment, handbooks, instructions, labels, andguidelines, robotic equipment, and the like.

In some embodiments, the systems employ pumps, reservoirs, tubing,wiring, or other components that provide materials on connectivity ofthe various components of the systems of the present invention. Forexample, any type of pump may be used to supply gas or liquid coolantsto the antennas of the present invention. Gas or liquid handling tankscontaining coolant may be employed in the system. In some embodiments,more than one tank is used such that as one tank becomes empty,additional tanks will be used automatically so as to prevent adisruption in a procedure (e.g., as one CO₂ tank is drained empty, asecond CO₂ tanks is used automatically thereby preventing proceduredisruption). In certain embodiments, the energy delivery systems (e.g.,the energy delivery device, the processor, the power supply, the imagingsystem, the temperature adjustment system, the temperature monitoringsystem, and/or the identification systems) and all related energydelivery system utilization sources (e.g., cables, wires, cords, tubes,pipes providing energy, gas, coolant, liquid, pressure, andcommunication items) are provided in a manner that reduces undesiredpresentation problems (e.g., tangling, cluttering, and sterilitycompromise associated with unorganized energy delivery systemutilization sources). The present invention is not limited to aparticular manner of providing the energy delivery systems and energydelivery system utilization sources such that undesired presentationproblems are reduced.

In some embodiments, a procedure device hub is employed that organizesand centralizes cables and minimizes clutter, while centralizes andconsolidating control features. For example, an import/export box may beused. In some embodiments, the import/export box contains the powersupply and coolant supply. In some embodiments, the import/export box islocated outside of a sterile field in which the patient is beingtreated. In some embodiments, the import/export box is located outsideof the room in which the patient is being treated. In some embodiments,one or more cables connect the import/export box to a procedure devicepod, which in turn is connected to and supplies energy and coolant to anenergy delivery device. In some embodiments, a single cable is used(e.g., a transport sheath). For example, in some such embodiments, atransport sheath contains components for delivery of both energy andcoolant to and/or from the import/export box. In some embodiments, thetransport sheath connects to the procedure device pod without causing aphysical obstacle for medical practitioners (e.g., travels under thefloor, overhead, etc). In some embodiments, the cable is a low-losscable (e.g., a low-loss cable attaching the power supply to theprocedure device hub). In some embodiments, the low-loss cable issecured (e.g., to the procedure device hub, to a procedure table, to aceiling) so as to prevent injury in the event of accidental pulling ofthe cable. In some embodiments, the cable connecting the power generator(e.g., microwave power generator) and the procedure device hub islow-loss reusable cable. In some embodiments, the cable connecting theprocedure device hub to the energy delivery device is flexibledisposable cable. In some embodiments, a CERTUS 140 microwave ablationsystem (NeuWave Medical, Madison, Wis.) is employed.

The present invention is not limited to a particular type or kind ofprocedure device pod. In some embodiments, the procedure device pod isconfigured to receive power, coolant, or other elements from theimport/export box or other sources. In some embodiments, the proceduredevice pod provides a control center, located physically near thepatient, for any one or more of: delivering energy to a medical device,circulating coolant to a medical device, collecting and processing data(e.g., imaging data, energy delivery data, safety monitoring data,temperature data, and the like), and providing any other function thatfacilitates a medical procedure. In some embodiments, the proceduredevice pod is configured to engage the transport sheath so as to receivethe associated energy delivery system utilization sources. In someembodiments, the procedure device pod is configured to receive anddistribute the various energy delivery system utilization sources to theapplicable devices (e.g., energy delivery devices, imaging systems,temperature adjustment systems, temperature monitoring systems, and/oridentification systems). For example, in some embodiments, the proceduredevice pod is configured to receive microwave energy and coolant fromenergy delivery system utilization sources and distribute the microwaveenergy and coolant to an energy delivery device. In some embodiments,the procedure device pod is configured to turn on or off, calibrate, andadjust (e.g., automatically or manually) the amount of a particularenergy delivery system utilization source as desired. In someembodiments, the procedure device pod has therein a power splitter foradjusting (e.g., manually or automatically turning on, turning off,calibrating) the amount of a particular energy delivery systemutilization source as desired. In some embodiments, the procedure devicepod has therein software designed to provide energy delivery systemutilization sources in a desired manner. In some embodiments, theprocedure device pod has a display region indicating associatedcharacteristics for each energy delivery system utilization source(e.g., which devices are presently being used/not used, the temperaturefor a particular body region, the amount of gas present in a particularCO₂ tank, etc.). In some embodiments, the display region has touchcapability (e.g., a touch screen). In some embodiments, the processorassociated with the energy delivery system is located in the proceduredevice pod. In some embodiments, the power supply associated with theenergy delivery systems is located within the procedure device pod. Insome embodiments, the procedure device pod has a sensor configured toautomatically inhibit one or more energy delivery system utilizationsources upon the occurrence of an undesired event (e.g., undesiredheating, undesired leak, undesired change in pressure, etc.). In someembodiments, the weight of the procedure device hub is such that itcould be placed onto a patient without causing discomfort and/or harm tothe patient (e.g., less than 15 pounds, less than 10 pounds, less than 5pounds).

FIG. 7 provides an example of a component of a pod for connecting anenergy delivery device to energy and coolant supplies. The componentcontains a housing 700 (shown in cutaway to reveal the internalcomponents). A coolant connection component 710 supply (e.g., Swagelok,SS-QM2-S-100 for quick connection) extends out of the housing to connectto a coolant. An ablative energy connection component 720 (e.g., a QMAconnector for quick connection) extends out of the housing to connect toa generator. An electrical connection component 730 extends out of thehousing to connect to an electrical source. A strain relief 740 isprovided through which the proximal end of an energy delivery devicecable is inserted and connected to the energy and coolant supplies.

In some embodiments, a hollow inner conductor of the energy deliverydevice is directly coupled with the coolant connection component 710(e.g., soldered together). In some such embodiments, the ablative energysource is also coupled to the coolant connection component 710 by acable that attaches on one end to the interior end of the energyconnection component 720 and on the other end to the inner conductorthrough the coolant connection component 710. As such, both the coolantand energy are linked together in the same interconnector (710). In somesuch embodiments, the energy cable attaches to the inner conductor at aright angle at a distance of ¼ wavelength from its end. As such, a wavereflected back is cancelled out, preventing energy from reflecting back.

In some embodiments, the housing 700 further comprises a pressure sensor(not shown). The pressure sensor monitors coolant flow via any desiredmechanism (e.g., flow sensor; pressure sensor; differential analysis attwo different points; flow change at one point; etc.). In the event thataberrant coolant flow is identified, an alarm is triggered and/or systemparameters are automatically altered (e.g., power off, coolant off).

In some embodiments, the procedure device pod is designed for locationwithin a sterile setting. In some embodiments, the procedure device podis positioned on a patient's bed, a table that the patient is on (e.g.,a table used for CT imaging, ultrasound imaging, MRI imaging, etc.), orother structure near the patient (e.g., the CT gantry). In someembodiments, the procedure device pod is positioned on a separate table.In some embodiments, the procedure device pod is attached to a ceiling.In some embodiments, the procedure device pod is attached to a ceilingsuch that a user (e.g., a physician) may move it into a desired position(thereby avoiding having to position the energy delivery systemutilization sources (e.g., cables, wires, cords, tubes, pipes providingenergy, gas, coolant, liquid, pressure, and communication items) on ornear a patient while in use). In some embodiments, the procedure devicehub is positioned to lay on a patient (e.g., on a patient's legs,thighs, waist, chest). In some embodiments, the procedure device hub ispositioned above a patient's head or below a patient's feet. In someembodiments, the procedure device hub has Velcro permitting attachmentonto a desired region (e.g., a procedure table, a patient's drape and/orgown).

In some embodiments, the procedure device hub is configured forattachment to a procedure strap used for medical procedures (e.g., a CTsafety strap). In some embodiments, the procedure strap attaches to aprocedure table (e.g., a CT table) (e.g., through a slot on the sides ofthe procedure table, through Velcro, through adhesive, through suction)and is used to secure a patient to the procedure table (e.g., throughwrapping around the patient and connecting with, for example, Velcro).The procedure device hub is not limited to a particular manner ofattachment with a procedure strap. In some embodiments, the proceduredevice hub is attached to the procedure strap. In some embodiments, theprocedure device hub is attached to a separate strap permittingreplacement of the procedure strap. In some embodiments, the proceduredevice hub is attached to a separate strap configured to attach to theprocedure strap. In some embodiments, the procedure device hub isattached to a separate strap configured to attach to any region of theprocedure table. In some embodiments, the procedure device hub isattached to a separate strap having insulation and/or padding to ensurepatient comfort.

In some embodiments, the procedure device hub is configured forattachment to a procedure ring. The present invention is not limited toa particular type or kind of procedure ring. In some embodiments, theprocedure ring is configured for placement around a patient (e.g.,around a patient's torso, head, feet, arm, etc.). In some embodiments,the procedure ring is configured to attach to a procedure table (e.g., aCT table). The procedure device ring is not limited to a particularshape. In some embodiments, the procedure device ring is, for example,oval, circular, rectangular, diagonal, etc. In some embodiments, theprocedure device ring is approximately half of a cyclical shape (e.g.,25% of a cyclical shape, 40% of a cyclical shape, 45% of a cyclicalshape, 50% of a cyclical shape, 55 of a cyclical shape, 60 of a cyclicalshape, 75 of a cyclical shape). In some embodiments, the procedure ringis, for example, metal, plastic, graphite, wood, ceramic, or anycombination thereof. The procedure device hub is not limited to aparticular manner of attachment to the procedure ring. In someembodiments, the procedure device hub attaches onto the procedure ring(e.g., with Velcro, with snap-ons, with an adhesive agent). In someembodiments utilizing low-loss cables, the low-loss cables additionalattach onto the procedure ring. In some embodiments, the size of theprocedure ring can be adjusted (e.g., retracted, extended) toaccommodate the size of a patient. In some embodiments, additional itemsmay be attached to the procedure ring. In some embodiments, theprocedure ring may be easily moved to and from the vicinity of apatient.

In some embodiments, the procedure device hub is configured forattachment onto a custom sterile drape. The present invention is notlimited to a particular type or kind of custom sterile drape. In someembodiments, the custom sterile drape is configured for placement onto apatient (e.g., onto a patient's torso, head, feet, arm, entire body,etc.). In some embodiments, the custom sterile drape is configured toattach to a procedure table (e.g., a CT table). The custom sterile drapeis not limited to a particular shape. In some embodiments, the customsterile drape is, for example, oval, circular, rectangular, diagonal,etc. In some embodiments, the shape of the custom sterile drape is suchthat it accommodates a particular body region of a patient. In someembodiments, the procedure ring is, for example, cloth, plastic, or anycombination thereof. The procedure device hub is not limited to aparticular manner of attachment to the custom sterile drape. In someembodiments, the procedure device hub attaches onto the custom steriledrape (e.g., with Velcro, with snap-ons, with an adhesive agent, clamps(e.g., alligator clamps)). In some embodiments utilizing low-losscables, the low-loss cables additional attach onto the custom steriledrape. In some embodiments, additional items may be attached to thecustom sterile drape. In some embodiments, the custom sterile drape maybe easily moved to and from the vicinity of a patient. In someembodiments, the custom sterile drape has one more fenestrations forpurposes of performing medical procedures.

In some embodiments, the procedure device hub is configured with legsfor positioning the hub in the vicinity of a patient. In someembodiments, the procedure device hub has adjustable legs (e.g., therebyallowing positioning of the procedure device hub in a variety ofpositions). In some embodiments, the procedure device hub has threeadjustable legs thereby allowing the device to be positioned in varioustri-pod positions. In some embodiments, the legs have therein Velcropermitting attachment onto a desired region (e.g., a procedure table, apatient's drape and/or gown). In some embodiments, the legs are formedfrom a springy material configured to form an arc over the proceduretable (e.g., CT table) and squeeze the rails of the procedure table. Insome embodiments, the legs are configured to attach onto the rails ofthe procedure table. In some embodiments, the procedure hub is attacheddirectly or indirectly to an arm, which may be connected to a bed frameor procedure table rail.

In some embodiments, the procedure device pod is configured tocommunicate (wirelessly or via wire) with a processor (e.g., a computer,with the Internet, with a cellular phone, with a PDA). In someembodiments, the procedure device hub may be operated via remotecontrol. In some embodiments, the procedure device pod has thereon oneor more lights. In some embodiments, the procedure device hub provides adetectable signal (e.g., auditory, visual (e.g., pulsing light)) whenpower is flowing from the procedure device hub to an energy deliverydevice. In some embodiments, the procedure device hub has an auditoryinput (e.g., an MP3 player). In some embodiments, the procedure devicehub has speakers for providing sound (e.g., sound from an MP3 player).In some embodiments, the procedure device hub has an auditory output forproviding sound to an external speaker system. In some embodiments, theuse of a procedure device pod permits the use of shorter cables, wires,cords, tubes, and/or pipes (e.g., less than 4 feet, 3 feet, 2 feet). Insome embodiments, the procedure device pod and/or one more componentsconnected to it, or portions thereof are covered by a sterile sheath. Insome embodiments, the procedure device hub has a power amplifier forsupplying power (e.g., to an energy delivery device).

In some embodiments, the procedure device pod is configured to compresstransported coolants (e.g., CO₂) at any desired pressure so as to, forexample, retain the coolant at a desired pressure (e.g., the criticalpoint for a gas) so as to improve cooling or temperature maintenance.For example, in some embodiments, a gas is provided at or near itscritical point for the purpose of maintaining a temperature of a device,line, cable, or other component at or near a constant, definedtemperature. In some such embodiments, a component is not cooled per se,in that its temperature does not drop from a starting temperature (e.g.,room temperature), but instead is maintained at a constant temperaturethat is cooler than where the component would be, but for theintervention. For example, CO₂ may be used at or near its critical point(e.g., 31.1 Celsius at 78.21 kPa) to maintain temperature so thatcomponents of the system are sufficiently cool enough not to burntissue, but likewise are not cooled or maintained significantly belowroom temperature or body temperature such skin in contact with thecomponent freezes or is otherwise damaged by cold. Using suchconfigurations permits the use of less insulation, as there are not“cold” components that must be shielded from people or from the ambientenvironment. In some embodiments, the procedure device pod has aretracting element designed to recoil used and/or unused cables, wires,cords, tubes, and pipes providing energy, gas, coolant, liquid,pressure, and/or communication items. In some embodiments, the proceduredevice pod is configured to prime coolants for distribution into, forexample, an energy delivery device such that the coolant is at a desiredtemperature prior to use of the energy delivery device. In someembodiments, the procedure device pod has therein software configured toprime coolants for distribution into, for example, an energy deliverydevice such that the system is at a desired temperature prior to use ofthe energy delivery device. In some embodiments, the circulation ofcoolants at or near critical point permits cooling of the electronicelements of the energy delivery devices without having to use additionalcooling mechanisms (e.g., fans).

In one illustrative embodiment, an import/export box contains one ormore microwave power sources and a coolant supply (e.g., pressurizedcarbon dioxide gas). This import/export box is connected to a singletransport sheath that delivers both the microwave energy and coolant toa procedure device pod. The coolant line or the energy line within thetransport sheath may be wound around one another to permit maximumcooling of the transport sheath itself. The transport sheath is run intothe sterile field where a procedure is to take place along the floor ina location that does not interfere with the movement of the medical teamattending to the patient. The transport sheath connects to a tablelocated near an imaging table upon which a patient lays. The table isportable (e.g., on wheels) and connectable to the imaging table so thatthey move together. The table contains arm, which may be flexible ortelescoping, so as to permit positioning of the arm above and over thepatient. The transport sheath, or cables connected to the transportsheath, run along the arm to the overhead position. At the end of thearm is the procedure device pod. In some embodiments, two or more armsare provided with two or more procedure device pods or two or moresub-components of a single procedure device pod. The procedure devicepod is small (e.g., less than 1 foot cube, less than 10 cm cube, etc.)to allow easy movement and positioning above the patient. The proceduredevice pod contains a processor for controlling all computing aspects ofthe system. The device pod contains one or more connections ports forconnecting cables that lead to energy delivery devices. Cables areconnected to the ports. The cables are retractable and less than threefeet in length. Use of short cables reduces expense and prevents powerloss. When not in use, the cables hang in the air above the patient, outof contact with the patient's body. The ports are configured with adummy load when not in use (e.g., when an energy delivery device is notconnected to a particular port). The procedure device pod is withinreach of the treating physician so that computer controls can beadjusted and displayed information can be viewed, in real-time, during aprocedure.

X. Uses for Energy Delivery Systems

The systems of the present invention are not limited to particular uses.Indeed, the energy delivery systems of the present invention aredesigned for use in any setting wherein the emission of energy isapplicable. Such uses include any and all medical, veterinary, andresearch applications. In addition, the systems and devices of thepresent invention may be used in agricultural settings, manufacturingsettings, mechanical settings, or any other application where energy isto be delivered.

In some embodiments, the present invention provides systems that accessto a difficult to reach region of the body (e.g. the periphery orcentral regions of the lungs). In some embodiments, the system navigatesthrough a branched body structure (e.g. bronchial tree) to reach atarget site. In some embodiments, systems, devices, and methods providedelivery of energy (e.g. microwave energy, energy for tissue ablation)to difficult to reach regions of a body, organ, or tissue (e.g. theperiphery or central region of the lungs). In some embodiments, thesystem delivers energy (e.g. microwave energy, energy for tissueablation) to a target site though a branched structure (e.g. bronchialtree). In some embodiments, the system delivers energy (e.g. microwaveenergy, energy for tissue ablation) to the periphery or central regionof the lungs through the bronchi (e.g. primary bronchi, secondarybronchi, tertiary bronchi, bronchioles, etc.). In some embodiments,accessing the lungs through the bronchi provides a precise and accurateapproach while minimizing collateral damage to the lungs. Accessing thelung (e.g. central lung or lung periphery) from outside the lungrequires puncturing or cutting the lung, which can be avoided bybronchial access.

In some embodiments, a primary catheter (e.g. endoscope, bronchoscope,etc.), containing a channel catheter and steerable navigation catheteris advanced into the bronchial tree (e.g. via the trachea) until thedecreasing circumference of the bronchi will not allow furtheradvancement of the primary catheter. In some embodiments, a primarycatheter (e.g. endoscope, bronchoscope, etc.), containing a channelcatheter and steerable navigation catheter is advanced into thebronchial tree (e.g. via the trachea) up to the desired point fordeployment of the channel catheter. In some embodiments, the primarycatheter is advanced into the trachea, primary bronchi, and/or secondarybronchi, but not further. In some embodiments, a channel cathetercontaining a steerable navigation catheter is advanced through theprimary catheter, and beyond the distal tip of the primary catheter,into the bronchial tree (e.g. via the trachea, via the primary bronchi,via secondary bronchi, via tertiary bronchi, via bronchioles, etc.) upto the target location (e.g. treatment site, tumor, etc.). In someembodiments, a channel catheter containing a steerable navigationcatheter is advanced into the bronchial tree (e.g. via the trachea,primary bronchi, etc.) until the decreasing size of the bronchi will notallow further advancement (e.g. in the tertiary bronchi, in thebronchioles, at the treatment site). In some embodiments, the channelcatheter is advanced into the trachea, primary bronchi, secondarybronchi, tertiary bronchi, and/or bronchioles. In some embodiments, thesteerable navigation catheter is advanced into the trachea, primarybronchi, secondary bronchi, tertiary bronchi, and/or bronchioles to thetreatment site. In some embodiments, the steerable navigation catheteris withdrawn through the channel catheter, leaving the open channellumen extending from the point of insertion (e.g. into the subject, intothe trachea, into the bronchial tree, etc.), through the bronchial tree(e.g. through the trachea, primary bronchi, secondary bronchi, tertiarybronchi, bronchioles, etc.) to the target site (e.g. treatment site,tumor, central or peripheral lunch tumor). In some embodiments, anenergy delivery device (e.g. microwave ablation device) is insertedthrough the open channel lumen to access the target site. In someembodiments, the present invention provides systems, devices, and methodto access central or peripheral lung tumors through the bronchial treewith a microwave ablation device.

In some embodiments, transbronchial treatment is employed. In suchembodiments, the devices are positioned through the airways (e.g.,following bronchial tree) to the best straight line or other desiredpath to the target. The airway wall is then pierced and the device isadvanced in proximity to the target to facilitate ablation.

In some embodiments, the present invention provides systems, methods,and devices for placement of an energy delivery device at a difficult toaccess tissue region within a subject. In some embodiments, the presentinvention provides placement of an energy delivery device for tissueablation therapy (e.g. tumor ablation). In some embodiments, the presentinvention provides access to, and/or treatment of, tumors, growths,and/or nodules on the periphery of the lungs or in the central lungs. Insome embodiments, the present invention provides access to, and ablationof, peripheral pulmonary nodules. Peripheral pulmonary nodules andcentral nodules are difficult to access through the bronchial treebecause of their location near the tertiary bronchi and bronchioles,beyond the reach of conventional devices and techniques. In someembodiments, devices, systems, and methods of the present inventionprovide access to central and peripheral pulmonary nodules through thebronchial tree. Peripheral pulmonary nodules are generally less than 25mm in diameter (e.g. <25 mm, <20 mm, <10 mm, <5 mm, <2 mm, <1 mm, etc.).In some embodiments, peripheral pulmonary nodules are 0.1 mm-25 mm indiameter (e.g. 0.1 mm . . . 0.2 mm . . . 0.5 mm . . . 1.0 mm . . . 1.4mm . . . 2.0 mm . . . 5.0 mm . . . 10 mm . . . 20 mm . . . 25 mm, anddiameters therein). In some embodiments, the present invention providesaccess and treatment of tumors, growths, and nodules of any size and anylocation within a subject (e.g. within the lungs of a subject). In someembodiments, the present invention provides curative treatment and/orpalliative treatment of tumors (e.g. nodules) in the central orperipheral lung.

XI. Device Placement Systems

In some embodiments, the present invention provides a primary catheter(e.g. endoscope, bronchoscope, etc.). In some embodiments, any suitableendoscope or bronchoscope known to those in the art finds use as aprimary catheter in the present invention. In some embodiments, aprimary catheter adopts characteristics of one or more endoscopes and/orbronchoscopes known in the art, as well as characteristics describedherein. One type of conventional flexible bronchoscope is described inU.S. Pat. No. 4,880,015, herein incorporated by reference in itsentirety. The bronchoscope measures 790 mm in length and has two mainparts, a working head and an insertion tube. The working head containsan eyepiece; an ocular lens with a diopter adjusting ring; attachmentsfor suction tubing, a suction valve, and light source; and an accessport or biopsy inlet, through which various devices and fluids can bepassed into the working channel and out the distal end of thebronchoscope. The working head is attached to the insertion tube, whichtypically measures 580 mm in length and 6.3 mm in diameter. Theinsertion tube contains fiberoptic bundles, which terminate in theobjective lens at the distal tip, light guides, and a working channel.Other endoscopes and bronchoscopes which may find use in embodiments ofthe present invention, or portions of which may find use with thepresent invention, are described in U.S. Pat. No. 7,473,219; U.S. Pat.No. 6,086,529; U.S. Pat. No. 4,586,491; U.S. Pat. No. 7,263,997; U.S.Pat. No. 7,233,820; and U.S. Pat. No. 6,174,307.

In some embodiments, the present invention provides a channel catheter(a.k.a. guide catheter, sheath, sheath catheter, etc.). In someembodiments, a guide catheter is configured to fit within the lumen of aprimary catheter and contains a channel lumen of sufficient diameter(e.g. 1 mm . . . 2 mm . . . 3 mm . . . 4 mm . . . 5 mm) to accommodate asteerable navigation catheter and/or one or more suitable tools (e.g.energy delivery device). In some embodiments, a channel catheter is ofsufficient length to extend from an insertion site (e.g. mouth, incisioninto body of subject, etc.) through the trachea and/or bronchial tree toa treatment site in the central or peripheral lung (e.g. 50 cm . . . 75cm . . . 1 m . . . 1.5 m . . . 2 m). In some embodiments, a channelcatheter is of sufficient length to extend beyond the reach of a primarycatheter to reach a treatment site (e.g. central or peripheral lungtissue). In some embodiments, a channel catheter is highly flexible toaccess a circuitous route through a subject (e.g. through a branchedstructure, through the bronchial tree, etc.). In some embodiments, achannel catheter is constructed of braided material to provide bothstrength and flexibility, as is understood in the art. In someembodiments, a channel catheter comprises the outer conductor of atriaxial or coaxial transmission line. In some embodiments, a channelcatheter comprises a navigation and/or steering mechanism. In someembodiments, a channel catheter is without an independent means ofnavigation, position recognition, or maneuvering. In some embodiments, achannel catheter relies upon the primary catheter or steerablenavigation catheter for placement.

In some embodiments, the present invention provides a steerablenavigation catheter. In some embodiments, a steerable navigationcatheter is configured to fit within the lumen of a channel catheter. Insome embodiments, a steerable navigation catheter has a similar diameterto energy transmission lines described herein (e.g. 0.2 mm . . . 0.5 mm. . . 1.0 mm . . . 1.5 mm . . . 2.0 mm). In some embodiments, asteerable navigation catheter is of sufficient length to extend from aninsertion site (e.g. mouth, incision into body of subject, etc.) to atreatment site (e.g. through the trachea and/or bronchial tree to atreatment site in the central or peripheral lung (e.g. 50 cm . . . 75 cm. . . 1 m . . . 1.5 m . . . 2 m). In some embodiments, a channelcatheter is of sufficient length to extend beyond the reach of a primarycatheter to reach a treatment site (e.g. central or peripheral lungtissue). In some embodiments, a steerable navigation catheter engages achannel catheter such that movement of the steerable navigation catheterresults in synchronous movement of the channel catheter. In someembodiments, as a steerable navigation catheter is inserted along a pathin a subject, the channel catheter surrounding the steerable navigationcatheter moves with it. In some embodiments, a channel catheter isplaced within a subject by a steerable navigation catheter. In someembodiments, a steerable navigation catheter can be disengaged from achannel catheter. In some embodiments, disengagement of a steerablenavigation catheter and channel catheter allows movement of thesteerable navigation catheter further along a pathway without movementof the channel catheter. In some embodiments, disengagement of asteerable navigation catheter and channel catheter allows retraction ofthe steerable navigation catheter through the channel catheter withoutmovement of the channel catheter.

In some embodiments, all inserted components of a system or device areconfigured for movement along a narrow and circuitous path through asubject (e.g. through a branched structure, through the bronchial tree,etc.). In some embodiment, components comprise a flexible materialconfigured for tight turning radiuses. In some embodiment, necessarilyrigid components are reduced in size (e.g. short length) to allow fortight turning radiuses.

All publications and patents mentioned in the above specification areherein incorporated by reference. Various modifications and variationsof the described method and system of the invention will be apparent tothose skilled in the art without departing from the scope and spirit ofthe invention. Although the invention has been described in connectionwith specific embodiments, it should be understood that the invention asclaimed should not be unduly limited to such specific embodiments.Indeed, various modifications of the described modes for carrying outthe invention that are obvious to those skilled in the relevant fieldsare intended to be within the scope of the following claims.

We claim:
 1. An energy delivery device for delivering microwave energyto a distant region of a body, comprising: a) a proximal end connectableto a microwave energy generator and a coolant source; b) a distal endconfigured to generate ablative energy in a defined region surroundingsaid distal end; c) a hollow inner conductor; d) a central regioncomprising a non-conductive core and an air channel; f) an outerconductor surrounding said core; and g) a coolant flow exchanger at thedistal end configured to receive coolant from said hollow innerconductor and return coolant to said air gap.
 2. The device of claim 1,wherein said central region comprises a spacer surrounding a portion ofsaid inner conductor and said non-conductive core surrounding saidspacer, whereby an air gap is formed between said core and said innerconductor in regions not occupied by said spacer.
 3. The device of claim1, wherein said energy delivery device is at least 20 centimeter long.4. The device of claim 1, further comprising a non-conductive jacketsurrounding said outer conductor and a conductive sheath surroundingsaid non-conductive jacket, said conductive sheath forming a triaxialantenna with said outer conductor and said inner conductor.
 5. Thedevice of claim 1, wherein said spacer comprises a monofilament tube,wherein said monofilament tube is wound spirally around said innerconductor.
 6. The device of claim 1, wherein said distal end comprises aconductive trocar.
 7. The device of claim 6, wherein said innerconductor is not electrically connected to said trocar, wherein saidinner conductor is capacitively coupled to said trocar.
 8. The device ofclaim 1, wherein said coolant flow exchanger comprise a cap having anopen proximal end forming an opening within said cap and a closed distalend.
 9. The device of claim 8, wherein said inner conductor is insertedinto said opening in said cap, wherein said opening in said capcomprising one or more channels that return coolant from said innerconductor out of said open proximal end of said cap and into said airgap.
 10. The device of claim 1, wherein said device has an outerdiameter sized for endobronchial delivery of microwave energy to acentral or peripheral lung nodule.
 11. A system comprising an energydelivery device of claim 1 and one or more of a delivery tube, amicrowave generator, a coolant supply, a control computer, an imagingdevice, and a power and coolant interface.
 12. The system of claim 11,wherein said coolant supply comprises a pressurized gas.
 13. The systemof claim 12, wherein said pressurized gas is CO₂.
 14. The system ofclaim 11, wherein said coolant supply delivers coolant through saidinner conductor of said energy delivery device at zero to 1000 psi. 15.The system of claim 11, wherein said interface comprises: a) an gasconnector for connecting to a coolant source; b) a power connector forconnecting to an electrical source; and c) an ablative power connectorfor connecting to a microwave generator.
 16. A method of ablating atissue comprising: positioning the distal end of an energy deliverydevice of claim 1 near a target tissue and applying ablative energy fromsaid device.
 17. The method of claim 16, wherein said target tissue isin a lung.
 18. The method of claim 17, wherein said energy deliverydevice is positioned endobronchially or transbronchially.
 19. The methodof claim 18, wherein said target tissue is a central or peripheral lungnodule.